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This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
ComplianceOnline
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times. But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare? In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare. About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business. About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...
YourEncoreInc
CE marking and CE certification what is it why you need it who can apply CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay. Visit: http://www.meddevicecorp.com/
CE marking and CE certification
CE marking and CE certification
meddevicemarking
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
Malaysia Medical Devices Regulations
Malaysia Medical Devices Regulations
Mourad Kholti
Medical Device Directive
MDD 93/42/EEC
MDD 93/42/EEC
Pavan Kumar Malwade
Turning compliance into competitive advantage
Addressing the challenge of the new European Union Medical Device Regulation
Addressing the challenge of the new European Union Medical Device Regulation
EY Belgium
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates. Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009. By Jan van Lochem, Gert Bos and Suzanne Halliday. Seminar “Regulatory update on medical devices in Asia and EU”. It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...
EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...
BSI British Standards Institution
The basics to understand what the European PV modules are and what they entail.
EU PV Modules - What are they?
EU PV Modules - What are they?
Vaska Toné
Recommandé
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
ComplianceOnline
The new EU Medical Device Regulation (MDR) represents one of the most disruptive changes to impact the global medical technology sector in recent times. But with the regulations not finalized, three years to comply, and overall fatigue on the topic, what are the appropriate steps companies should take today to prepare? In this session, Minnie Baylor-Henry and Jon Lange will briefly outline the current state of EU MDR, its likely impact to medtech company strategy and compliance requirements, and provide appropriate steps companies should take today to prepare. About Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices Practice Lead. Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business. About Jon Lange: Jon Lange is a Principal in the Advisory Services practice of EY and its EU MDR lead. He has spent 25+ years leading strategic growth initiatives and business transformation change programs for large and mid-tier life science companies.
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...
YourEncoreInc
CE marking and CE certification what is it why you need it who can apply CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay. Visit: http://www.meddevicecorp.com/
CE marking and CE certification
CE marking and CE certification
meddevicemarking
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
Malaysia Medical Devices Regulations
Malaysia Medical Devices Regulations
Mourad Kholti
Medical Device Directive
MDD 93/42/EEC
MDD 93/42/EEC
Pavan Kumar Malwade
Turning compliance into competitive advantage
Addressing the challenge of the new European Union Medical Device Regulation
Addressing the challenge of the new European Union Medical Device Regulation
EY Belgium
BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates. Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009. By Jan van Lochem, Gert Bos and Suzanne Halliday. Seminar “Regulatory update on medical devices in Asia and EU”. It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...
EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...
BSI British Standards Institution
The basics to understand what the European PV modules are and what they entail.
EU PV Modules - What are they?
EU PV Modules - What are they?
Vaska Toné
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Akshay Anand
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives. Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Pallavi Christeen
brief description about medical devices and CE certification process. declaration of conformity and technical files submission in order to obtain CE mark for medical devices.
Ce marking of medical devices
Ce marking of medical devices
Pallavi Christeen
Medical devices for_the_eu_070910
Medical devices for_the_eu_070910
Ondina Grigorescu
A comprehensive look at a series of presentations on quality and compliance, recently presented in partnership with the ABHI in London.
The ROI of Good Quality & Compliance
The ROI of Good Quality & Compliance
Maetrics
This presentation provided an overview on manufacturing medical devices and the regulatory considerations
Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devices
TGA Australia
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.
Maetrics
A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes. The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices. So what exactly are the implications of all these changes for device manufactures? How does this affect your CERs? How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs). Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st. (You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4) Specifically, you will learn: What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers? What are some of the most significant changes? (There are a lot of them) How does it align with the changes to the new EU MDR? In what ways will demonstrating “equivalence” now be harder? How often you must update your CERs now and what qualifications the evaluators must have? How should you prepare for the increased notified body scrutiny? How do you perform a clinical literature review to meet the new expectations? Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Greenlight Guru
The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
April Bright
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
NAMSA
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant. Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors. In this presentation you will learn: -Why the European regulations are changing -An overview of the text being voted on -What does the new regulation mean for manufactures -Examine the risk based approach to classification -Strategy for technical documentation preparation -Changes to clinical evidence for devices -Post market surveillance and vigilance for medical devices -What you can do to start preparing now -What are all the significant changes You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)
Greenlight Guru
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
April Bright
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)
Christian Dekoninck
Presentation by Ed Ball, Senior Associate, Maetrics Ltd at the Liverpool City Region SME workshop: regulatory process and approval at The Accelerator Building, Liverpool on Thursday 6 December.
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Innovation Agency
Currently, China is one of the world's most promising markets for medical devices, which on the back of its vast market size, offers huge potential to medical device companies. All medical devices marketed or sold for use in China must be registered with China Food and Drug Administration (CFDA).
Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_Edwin
CIRS China
This presentation provided an overview of the lifecycle approach to regulation & the importance of reporting incidents to the TGA
Presentation: Life cycle of medical devices
Presentation: Life cycle of medical devices
TGA Australia
CE Marking process
The ce marking process
The ce marking process
Lakshy Management Consultant Pvt Ltd
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3
Erik Vollebregt
Eu hot topics alliance presentation
Eu hot topics alliance presentation
Erik Vollebregt
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745
Monir EL AZZOUZI
Hi paa and eh rs
Hi paa and eh rs
supportc2go
Hipaa audits and enforcement
Hipaa audits and enforcement
supportc2go
Contenu connexe
Tendances
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Akshay Anand
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives. Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Pallavi Christeen
brief description about medical devices and CE certification process. declaration of conformity and technical files submission in order to obtain CE mark for medical devices.
Ce marking of medical devices
Ce marking of medical devices
Pallavi Christeen
Medical devices for_the_eu_070910
Medical devices for_the_eu_070910
Ondina Grigorescu
A comprehensive look at a series of presentations on quality and compliance, recently presented in partnership with the ABHI in London.
The ROI of Good Quality & Compliance
The ROI of Good Quality & Compliance
Maetrics
This presentation provided an overview on manufacturing medical devices and the regulatory considerations
Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devices
TGA Australia
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.
Maetrics
A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes. The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices. So what exactly are the implications of all these changes for device manufactures? How does this affect your CERs? How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs). Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st. (You can view the full webinar at: http://www.greenlight.guru/webinar/clinical-evaluation-eu-meddev-2_7_1-rev-4) Specifically, you will learn: What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers? What are some of the most significant changes? (There are a lot of them) How does it align with the changes to the new EU MDR? In what ways will demonstrating “equivalence” now be harder? How often you must update your CERs now and what qualifications the evaluators must have? How should you prepare for the increased notified body scrutiny? How do you perform a clinical literature review to meet the new expectations? Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Greenlight Guru
The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
April Bright
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
NAMSA
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant. Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors. In this presentation you will learn: -Why the European regulations are changing -An overview of the text being voted on -What does the new regulation mean for manufactures -Examine the risk based approach to classification -Strategy for technical documentation preparation -Changes to clinical evidence for devices -Post market surveillance and vigilance for medical devices -What you can do to start preparing now -What are all the significant changes You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)
Greenlight Guru
The Orthopaedic Surgical Manufacturers Association, a collective voice of orthopedic device companies that influences the decision of worldwide regulatory agencies and standards bodies, will highlight the main regulatory changes impacting the industry. This session is for any orthopedic professional who wants a forecast of regulatory pressures and seeks direction on how to shape change. Attendees will learn how FDA, European agencies and IMDRF are approaching harmonization and alignment of standards, regulations and guidance. OSMA Members will provide future trends and opportunities afforded via FDA’s National Evaluation System for Health Technology (NEST), facilitation of innovation through partnerships and global harmonization of regulatory submissions and facility assessments.
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
April Bright
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)
Christian Dekoninck
Presentation by Ed Ball, Senior Associate, Maetrics Ltd at the Liverpool City Region SME workshop: regulatory process and approval at The Accelerator Building, Liverpool on Thursday 6 December.
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Innovation Agency
Currently, China is one of the world's most promising markets for medical devices, which on the back of its vast market size, offers huge potential to medical device companies. All medical devices marketed or sold for use in China must be registered with China Food and Drug Administration (CFDA).
Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_Edwin
CIRS China
This presentation provided an overview of the lifecycle approach to regulation & the importance of reporting incidents to the TGA
Presentation: Life cycle of medical devices
Presentation: Life cycle of medical devices
TGA Australia
CE Marking process
The ce marking process
The ce marking process
Lakshy Management Consultant Pvt Ltd
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3
Erik Vollebregt
Eu hot topics alliance presentation
Eu hot topics alliance presentation
Erik Vollebregt
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745
Monir EL AZZOUZI
Tendances
(20)
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Ce marking of medical devices
Ce marking of medical devices
Medical devices for_the_eu_070910
Medical devices for_the_eu_070910
The ROI of Good Quality & Compliance
The ROI of Good Quality & Compliance
Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devices
Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_Edwin
Presentation: Life cycle of medical devices
Presentation: Life cycle of medical devices
The ce marking process
The ce marking process
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation
Eu hot topics alliance presentation
Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745
En vedette
Hi paa and eh rs
Hi paa and eh rs
supportc2go
Hipaa audits and enforcement
Hipaa audits and enforcement
supportc2go
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2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Markin...
2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Markin...
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Dmf
Dmf
supportc2go
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Hipaa random audit
supportc2go
En vedette
(6)
Hi paa and eh rs
Hi paa and eh rs
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Hipaa audits and enforcement
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2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Markin...
2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Markin...
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Dmf
Hipaa random audit
Hipaa random audit
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We will cover: • Overview of proposed changes to ISO 13485:201X, MDSAP • New EU regulations and unannounced audits • New directions for QMS and regulatory audits Presenter: This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1 March 2016.
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EU’s In Vitro Diagnostic Medical Device Regulation A quick guide to the new IVDR. The EU’s in vitro diagnostic medical device regulation Manufacturers of in vitro diagnostic medical devices seeking market access to the European Union (EU) will soon face major changes in the EU’s decades-old regulatory framework. The EU’s In vitro diagnostic medical device regulation (IVDR) was officially published on 5 May 2017 and came into force on 26 May 2017. The IVDR will replace the EU’s current directive on in vitro diagnostic medical devices (98/79/EC).
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The EU’s medical device regulation Medical device manufacturers seeking market access to the European Union (EU) will soon face major changes in the EU’s decades-old regulatory framework. The EU’s Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
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Global Institute Of Regulatory Affair comes up with some new courses....
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Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles. The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process. Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry. This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
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“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...
ulmedical
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year. The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system. Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive. The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant. Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors. This presentation includes: -Why the European regulations are changing -What does the new regulation mean for IVD manufactures -How to classify your IVD using the new risk-based classification system -How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark -An overview of all the most significant changes brought by the IVDR -What IVD manufactures can do to start preparing now Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
How to Prepare for the New EU In Vitro Diagnostics Regulations
How to Prepare for the New EU In Vitro Diagnostics Regulations
Greenlight Guru
Quality regulation for biological products current and future
Quality regulation for biological products current and future
National Institute of Biologics
Reg summary
Reg summary
ruyang89
Unique device identification
Unique device identification
complianceonline123
Webinar for Advamed members about the new EU medical devices and in vitro diagnostics regulation.
Advamed MDR IVDR update
Advamed MDR IVDR update
Erik Vollebregt
New IVD Medical Device Act
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
DrSivakumarSelvaraj
EMMA International Consulting Group CEO, Dr. Carmine Jabri, will be cohosting a webinar with Jan Flegeau, Director of Regulatory Affairs, to give an overview of what’s to come from the EU MDR.
The New EU MDR and What You Need to Know
The New EU MDR and What You Need to Know
EMMAIntl
Regulatory affairs
cmc [ chemistry manufacturing control ]
cmc [ chemistry manufacturing control ]
Akshay Patil
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three. You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)
PEPGRA Healthcare
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presentation-ema-experience-mdr-implementation_en.pdf
presentation-ema-experience-mdr-implementation_en.pdf
PECB Webinar: Proposed changes for medical device quality management systems ...
PECB Webinar: Proposed changes for medical device quality management systems ...
ISO 13485 Certification.pdf
ISO 13485 Certification.pdf
ISO 13485 Medical Manufature.pdf
ISO 13485 Medical Manufature.pdf
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device Regulation
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device Regulation
The EU’s Medical Device Regulation
The EU’s Medical Device Regulation
Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve...
Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve...
Medical Device Regulatory Affairs.
Medical Device Regulatory Affairs.
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Rigel Medical-The-Pulse-Issue-4
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...
How to Prepare for the New EU In Vitro Diagnostics Regulations
How to Prepare for the New EU In Vitro Diagnostics Regulations
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Quality regulation for biological products current and future
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Unique device identification
Advamed MDR IVDR update
Advamed MDR IVDR update
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
The New EU MDR and What You Need to Know
The New EU MDR and What You Need to Know
cmc [ chemistry manufacturing control ]
cmc [ chemistry manufacturing control ]
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)
Med Byte
Med Byte
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Understanding design
Understanding design
supportc2go
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Risk analysis
supportc2go
Hipaa audits and enforcement
Hipaa audits and enforcement
supportc2go
Hi paa and eh rs
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supportc2go
Excel spreadsheet
Excel spreadsheet
supportc2go
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supportc2go
Cots software
Cots software
supportc2go
Excel spreadsheet
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supportc2go
Live webinar on sop
Live webinar on sop
supportc2go
Gmp 1
Gmp 1
supportc2go
Dmf
Dmf
supportc2go
Capa
Capa
supportc2go
Post market
Post market
supportc2go
21 cfr part 11
21 cfr part 11
supportc2go
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Live webinar on lypolization
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Live Webinar on Lyophilization Process Development and Cycle Design
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Understanding design
Understanding design
Risk analysis
Risk analysis
Hipaa audits and enforcement
Hipaa audits and enforcement
Hi paa and eh rs
Hi paa and eh rs
Excel spreadsheet
Excel spreadsheet
Design history file
Design history file
Cots software
Cots software
Excel spreadsheet
Excel spreadsheet
Live webinar on sop
Live webinar on sop
Gmp 1
Gmp 1
Dmf
Dmf
Capa
Capa
Post market
Post market
21 cfr part 11
21 cfr part 11
Live webinar on lypolization
Live webinar on lypolization
Live Webinar on Lyophilization Process Development and Cycle Design
Live Webinar on Lyophilization Process Development and Cycle Design
Dernier
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