SlideShare une entreprise Scribd logo

2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

•Télécharger en tant que DOCX, PDF•
•
S
supportc2go

The document summarizes a live webinar on medical device regulations in the EU. The webinar will discuss EU directives, guidance documents, the CE marking process, and ISO certification requirements for commercializing medical devices in Europe. Attendees will learn about classifying devices and the regulatory requirements for approval and marketing in the EU. The webinar leader has over 27 years of experience in medical device regulation in Europe and globally.

BusinessSanté & Médecine
1  sur  4
[object Object]
2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

Recommandé

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...ComplianceOnline
 
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...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
CE marking and CE certificationCE marking and CE certification
CE marking and CE certificationmeddevicemarking
 
Malaysia Medical Devices Regulations
Malaysia Medical Devices RegulationsMalaysia Medical Devices Regulations
Malaysia Medical Devices RegulationsMourad Kholti
 
MDD 93/42/EEC
MDD 93/42/EECMDD 93/42/EEC
MDD 93/42/EECPavan Kumar Malwade
 
Addressing the challenge of the new European Union Medical Device Regulation
Addressing the challenge of the new European Union Medical Device RegulationAddressing the challenge of the new European Union Medical Device Regulation
Addressing the challenge of the new European Union Medical Device RegulationEY Belgium
 
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...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
 
EU PV Modules - What are they?
EU PV Modules - What are they? EU PV Modules - What are they?
EU PV Modules - What are they? Vaska Toné
 

Recommandé

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...ComplianceOnline
 
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...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
CE marking and CE certificationCE marking and CE certification
CE marking and CE certificationmeddevicemarking
 
Malaysia Medical Devices Regulations
Malaysia Medical Devices RegulationsMalaysia Medical Devices Regulations
Malaysia Medical Devices RegulationsMourad Kholti
 
MDD 93/42/EEC
MDD 93/42/EECMDD 93/42/EEC
MDD 93/42/EECPavan Kumar Malwade
 
Addressing the challenge of the new European Union Medical Device Regulation
Addressing the challenge of the new European Union Medical Device RegulationAddressing the challenge of the new European Union Medical Device Regulation
Addressing the challenge of the new European Union Medical Device RegulationEY Belgium
 
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...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
 
EU PV Modules - What are they?
EU PV Modules - What are they? EU PV Modules - What are they?
EU PV Modules - What are they? Vaska Toné
 
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
 
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
 
Ce marking of medical devices
Ce marking of medical devicesCe marking of medical devices
Ce marking of medical devicesPallavi Christeen
 
Medical devices for_the_eu_070910
Medical devices for_the_eu_070910Medical devices for_the_eu_070910
Medical devices for_the_eu_070910Ondina Grigorescu
 
The ROI of Good Quality & Compliance
The ROI of Good Quality & ComplianceThe ROI of Good Quality & Compliance
The ROI of Good Quality & ComplianceMaetrics
 
Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesPresentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesTGA Australia
 
Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.Maetrics
 
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Greenlight Guru
 
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckEU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckApril Bright
 
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...NAMSA
 
How to Prepare for the New 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)
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
 
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesOSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
 
Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
 
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Innovation Agency
 
Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinMedical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinCIRS China
 
Presentation: Life cycle of medical devices
Presentation: Life cycle of medical devicesPresentation: Life cycle of medical devices
Presentation: Life cycle of medical devicesTGA Australia
 
The ce marking process
The ce marking processThe ce marking process
The ce marking processLakshy Management Consultant Pvt Ltd
 
Eu hot topics alliance presentation
Eu hot topics alliance presentationEu hot topics alliance presentation
Eu hot topics alliance presentationErik Vollebregt
 
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3Erik Vollebregt
 
Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745Monir EL AZZOUZI
 
Hi paa and eh rs
Hi paa and eh rsHi paa and eh rs
Hi paa and eh rssupportc2go
 
Hipaa audits and enforcement
Hipaa audits and enforcementHipaa audits and enforcement
Hipaa audits and enforcementsupportc2go
 

Contenu connexe

Tendances

Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
 
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
 
Ce marking of medical devices
Ce marking of medical devicesCe marking of medical devices
Ce marking of medical devicesPallavi Christeen
 
Medical devices for_the_eu_070910
Medical devices for_the_eu_070910Medical devices for_the_eu_070910
Medical devices for_the_eu_070910Ondina Grigorescu
 
The ROI of Good Quality & Compliance
The ROI of Good Quality & ComplianceThe ROI of Good Quality & Compliance
The ROI of Good Quality & ComplianceMaetrics
 
Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesPresentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesTGA Australia
 
Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.Maetrics
 
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Greenlight Guru
 
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckEU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckApril Bright
 
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...NAMSA
 
How to Prepare for the New 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)
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
 
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesOSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
 
Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
 
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Innovation Agency
 
Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinMedical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinCIRS China
 
Presentation: Life cycle of medical devices
Presentation: Life cycle of medical devicesPresentation: Life cycle of medical devices
Presentation: Life cycle of medical devicesTGA Australia
 
Eu hot topics alliance presentation
Eu hot topics alliance presentationEu hot topics alliance presentation
Eu hot topics alliance presentationErik Vollebregt
 
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3Erik Vollebregt
 
Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745Monir 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 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...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 devicesCe marking of medical devices
Ce marking of medical devices
 
Medical devices for_the_eu_070910
Medical devices for_the_eu_070910Medical devices for_the_eu_070910
Medical devices for_the_eu_070910
 
The ROI of Good Quality & Compliance
The ROI of Good Quality & ComplianceThe ROI of Good Quality & Compliance
The ROI of Good Quality & Compliance
 
Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesPresentation: 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.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 ...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 BottleneckEU 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...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)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 OpportunitiesOSMA: 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)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 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_EdwinMedical 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 devicesPresentation: Life cycle of medical devices
Presentation: Life cycle of medical devices
 
The ce marking process
The ce marking processThe ce marking process
The ce marking process
 
Eu hot topics alliance presentation
Eu hot topics alliance presentationEu hot topics alliance presentation
Eu hot topics alliance presentation
 
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3
 
Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745
 

En vedette

Hi paa and eh rs
Hi paa and eh rsHi paa and eh rs
Hi paa and eh rssupportc2go
 
Hipaa audits and enforcement
Hipaa audits and enforcementHipaa audits and enforcement
Hipaa audits and enforcementsupportc2go
 
Preparing for fda
Preparing for fdaPreparing for fda
Preparing for fdasupportc2go
 
Hipaa random audit
Hipaa random auditHipaa random audit
Hipaa random auditsupportc2go
 

En vedette (6)

Hi paa and eh rs
Hi paa and eh rsHi paa and eh rs
Hi paa and eh rs
 
Hipaa audits and enforcement
Hipaa audits and enforcementHipaa audits and enforcement
Hipaa audits and enforcement
 
Preparing for fda
Preparing for fdaPreparing for fda
Preparing for fda
 
Dmf
DmfDmf
Dmf
 
Eu
EuEu
Eu
 
Hipaa random audit
Hipaa random auditHipaa random audit
Hipaa random audit
 

Similaire à 2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

presentation-ema-experience-mdr-implementation_en.pdf
presentation-ema-experience-mdr-implementation_en.pdfpresentation-ema-experience-mdr-implementation_en.pdf
presentation-ema-experience-mdr-implementation_en.pdfBalaji Kuzhandhaivelu
 
PECB Webinar: Proposed changes for medical device quality management systems ...
PECB Webinar: Proposed changes for medical device quality management systems ...PECB Webinar: Proposed changes for medical device quality management systems ...
PECB Webinar: Proposed changes for medical device quality management systems ...PECB
 
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device Regulation
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationTuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device Regulation
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
 
The EU’s Medical Device Regulation
The EU’s Medical Device RegulationThe EU’s Medical Device Regulation
The EU’s Medical Device RegulationStefano Bolletta
 
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...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...qserveconference2013
 
Medical Device Regulatory Affairs.
Medical Device Regulatory Affairs.Medical Device Regulatory Affairs.
Medical Device Regulatory Affairs.Anjali Gupta
 
Rigel Medical-The-Pulse-Issue-4
Rigel Medical-The-Pulse-Issue-4Rigel Medical-The-Pulse-Issue-4
Rigel Medical-The-Pulse-Issue-4Medical IT
 
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
 
How to Prepare for the New EU In Vitro Diagnostics Regulations
How to Prepare for the New EU In Vitro Diagnostics RegulationsHow to Prepare for the New EU In Vitro Diagnostics Regulations
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
 
Quality regulation for biological products current and future
Quality regulation for biological products current and futureQuality regulation for biological products current and future
Quality regulation for biological products current and futureNational Institute of Biologics
 
Reg summary
Reg summaryReg summary
Reg summaryruyang89
 
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptxDrSivakumarSelvaraj
 
The New EU MDR and What You Need to Know
The New EU MDR and What You Need to KnowThe New EU MDR and What You Need to Know
The New EU MDR and What You Need to KnowEMMAIntl
 
cmc [ chemistry manufacturing control ]
cmc [ chemistry manufacturing control ]cmc [ chemistry manufacturing control ]
cmc [ chemistry manufacturing control ]Akshay Patil
 
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)clinical-evaluation-report (CER)
clinical-evaluation-report (CER)PEPGRA Healthcare
 

Similaire à 2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs (20)

presentation-ema-experience-mdr-implementation_en.pdf
presentation-ema-experience-mdr-implementation_en.pdfpresentation-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 ...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.pdfISO 13485 Certification.pdf
ISO 13485 Certification.pdf
 
ISO 13485 Medical Manufature.pdf
ISO 13485 Medical Manufature.pdfISO 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 RegulationTuv 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 RegulationThe 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...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.Medical Device Regulatory Affairs.
Medical Device Regulatory Affairs.
 
Rigel Medical-The-Pulse-Issue-4
Rigel Medical-The-Pulse-Issue-4Rigel Medical-The-Pulse-Issue-4
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...“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 RegulationsHow to Prepare for the New EU In Vitro Diagnostics Regulations
How to Prepare for the New EU In Vitro Diagnostics Regulations
 
Quality regulation for biological products current and future
Quality regulation for biological products current and futureQuality regulation for biological products current and future
Quality regulation for biological products current and future
 
Reg summary
Reg summaryReg summary
Reg summary
 
Unique device identification
Unique device identificationUnique device identification
Unique device identification
 
Advamed MDR IVDR update
Advamed MDR IVDR updateAdvamed MDR IVDR update
Advamed MDR IVDR update
 
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx2. 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 KnowThe 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 ]cmc [ chemistry manufacturing control ]
cmc [ chemistry manufacturing control ]
 
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)clinical-evaluation-report (CER)
clinical-evaluation-report (CER)
 
Med Byte
Med ByteMed Byte
Med Byte
 

Plus de supportc2go

Understanding design
Understanding designUnderstanding design
Understanding designsupportc2go
 
Hipaa audits and enforcement
Hipaa audits and enforcementHipaa audits and enforcement
Hipaa audits and enforcementsupportc2go
 
Hi paa and eh rs
Hi paa and eh rsHi paa and eh rs
Hi paa and eh rssupportc2go
 
Excel spreadsheet
Excel spreadsheetExcel spreadsheet
Excel spreadsheetsupportc2go
 
Design history file
Design history fileDesign history file
Design history filesupportc2go
 
Excel spreadsheet
Excel spreadsheetExcel spreadsheet
Excel spreadsheetsupportc2go
 
Live webinar on sop
Live webinar on sopLive webinar on sop
Live webinar on sopsupportc2go
 
Live webinar on lypolization
Live webinar on lypolizationLive webinar on lypolization
Live webinar on lypolizationsupportc2go
 
Live Webinar on Lyophilization Process Development and Cycle Design
Live Webinar on Lyophilization Process Development and Cycle DesignLive Webinar on Lyophilization Process Development and Cycle Design
Live Webinar on Lyophilization Process Development and Cycle Designsupportc2go
 

Plus de supportc2go (16)

Understanding design
Understanding designUnderstanding design
Understanding design
 
Risk analysis
Risk analysisRisk analysis
Risk analysis
 
Hipaa audits and enforcement
Hipaa audits and enforcementHipaa audits and enforcement
Hipaa audits and enforcement
 
Hi paa and eh rs
Hi paa and eh rsHi paa and eh rs
Hi paa and eh rs
 
Excel spreadsheet
Excel spreadsheetExcel spreadsheet
Excel spreadsheet
 
Design history file
Design history fileDesign history file
Design history file
 
Cots software
Cots softwareCots software
Cots software
 
Excel spreadsheet
Excel spreadsheetExcel spreadsheet
Excel spreadsheet
 
Live webinar on sop
Live webinar on sopLive webinar on sop
Live webinar on sop
 
Gmp 1
Gmp 1Gmp 1
Gmp 1
 
Dmf
DmfDmf
Dmf
 
Capa
CapaCapa
Capa
 
Post market
Post marketPost market
Post market
 
21 cfr part 11
21 cfr part 1121 cfr part 11
21 cfr part 11
 
Live webinar on lypolization
Live webinar on lypolizationLive webinar on lypolization
Live webinar on lypolization
 
Live Webinar on Lyophilization Process Development and Cycle Design
Live Webinar on Lyophilization Process Development and Cycle DesignLive Webinar on Lyophilization Process Development and Cycle Design
Live Webinar on Lyophilization Process Development and Cycle Design
 

Dernier

Call Girls in Gomti Nagar - 7388211116 - With room Service
Call Girls in Gomti Nagar - 7388211116 - With room ServiceCall Girls in Gomti Nagar - 7388211116 - With room Service
Call Girls in Gomti Nagar - 7388211116 - With room Servicediscovermytutordmt
 
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...lizamodels9
 
Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023Neil Kimberley
 
7.pdf This presentation captures many uses and the significance of the number...
7.pdf This presentation captures many uses and the significance of the number...7.pdf This presentation captures many uses and the significance of the number...
7.pdf This presentation captures many uses and the significance of the number...Paul Menig
 
A DAY IN THE LIFE OF A SALESMAN / WOMAN
A DAY IN THE LIFE OF A SALESMAN / WOMANA DAY IN THE LIFE OF A SALESMAN / WOMAN
A DAY IN THE LIFE OF A SALESMAN / WOMANIlamathiKannappan
 
Cash Payment 9602870969 Escort Service in Udaipur Call Girls
Cash Payment 9602870969 Escort Service in Udaipur Call GirlsCash Payment 9602870969 Escort Service in Udaipur Call Girls
Cash Payment 9602870969 Escort Service in Udaipur Call GirlsApsara Of India
 
Russian Faridabad Call Girls(Badarpur) : ☎ 8168257667, @4999
Russian Faridabad Call Girls(Badarpur) : ☎ 8168257667, @4999Russian Faridabad Call Girls(Badarpur) : ☎ 8168257667, @4999
Russian Faridabad Call Girls(Badarpur) : ☎ 8168257667, @4999Tina Ji
 
0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdf0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdfRenandantas16
 
Tech Startup Growth Hacking 101 - Basics on Growth Marketing
Tech Startup Growth Hacking 101 - Basics on Growth MarketingTech Startup Growth Hacking 101 - Basics on Growth Marketing
Tech Startup Growth Hacking 101 - Basics on Growth MarketingShawn Pang
 
Call Girls In Panjim North Goa 9971646499 Genuine Service
Call Girls In Panjim North Goa 9971646499 Genuine ServiceCall Girls In Panjim North Goa 9971646499 Genuine Service
Call Girls In Panjim North Goa 9971646499 Genuine Serviceritikaroy0888
 
Regression analysis: Simple Linear Regression Multiple Linear Regression
Regression analysis: Simple Linear Regression Multiple Linear RegressionRegression analysis: Simple Linear Regression Multiple Linear Regression
Regression analysis: Simple Linear Regression Multiple Linear RegressionRavindra Nath Shukla
 
Grateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdfGrateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdfPaul Menig
 
It will be International Nurses' Day on 12 May
It will be International Nurses' Day on 12 MayIt will be International Nurses' Day on 12 May
It will be International Nurses' Day on 12 MayNZSG
 
BEST ✨ Call Girls In Indirapuram Ghaziabad ✔️ 9871031762 ✔️ Escorts Service...
BEST ✨ Call Girls In Indirapuram Ghaziabad ✔️ 9871031762 ✔️ Escorts Service...BEST ✨ Call Girls In Indirapuram Ghaziabad ✔️ 9871031762 ✔️ Escorts Service...
BEST ✨ Call Girls In Indirapuram Ghaziabad ✔️ 9871031762 ✔️ Escorts Service...noida100girls
 
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 
Progress Report - Oracle Database Analyst Summit
Progress Report - Oracle Database Analyst SummitProgress Report - Oracle Database Analyst Summit
Progress Report - Oracle Database Analyst SummitHolger Mueller
 
Best Basmati Rice Manufacturers in India
Best Basmati Rice Manufacturers in IndiaBest Basmati Rice Manufacturers in India
Best Basmati Rice Manufacturers in IndiaShree Krishna Exports
 

Dernier (20)

Call Girls in Gomti Nagar - 7388211116 - With room Service
Call Girls in Gomti Nagar - 7388211116 - With room ServiceCall Girls in Gomti Nagar - 7388211116 - With room Service
Call Girls in Gomti Nagar - 7388211116 - With room Service
 
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...
Call Girls In DLf Gurgaon ➥99902@11544 ( Best price)100% Genuine Escort In 24...
 
Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023
 
7.pdf This presentation captures many uses and the significance of the number...
7.pdf This presentation captures many uses and the significance of the number...7.pdf This presentation captures many uses and the significance of the number...
7.pdf This presentation captures many uses and the significance of the number...
 
A DAY IN THE LIFE OF A SALESMAN / WOMAN
A DAY IN THE LIFE OF A SALESMAN / WOMANA DAY IN THE LIFE OF A SALESMAN / WOMAN
A DAY IN THE LIFE OF A SALESMAN / WOMAN
 
Cash Payment 9602870969 Escort Service in Udaipur Call Girls
Cash Payment 9602870969 Escort Service in Udaipur Call GirlsCash Payment 9602870969 Escort Service in Udaipur Call Girls
Cash Payment 9602870969 Escort Service in Udaipur Call Girls
 
Russian Faridabad Call Girls(Badarpur) : ☎ 8168257667, @4999
Russian Faridabad Call Girls(Badarpur) : ☎ 8168257667, @4999Russian Faridabad Call Girls(Badarpur) : ☎ 8168257667, @4999
Russian Faridabad Call Girls(Badarpur) : ☎ 8168257667, @4999
 
Forklift Operations: Safety through Cartoons
Forklift Operations: Safety through CartoonsForklift Operations: Safety through Cartoons
Forklift Operations: Safety through Cartoons
 
0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdf0183760ssssssssssssssssssssssssssss00101011 (27).pdf
0183760ssssssssssssssssssssssssssss00101011 (27).pdf
 
Tech Startup Growth Hacking 101 - Basics on Growth Marketing
Tech Startup Growth Hacking 101 - Basics on Growth MarketingTech Startup Growth Hacking 101 - Basics on Growth Marketing
Tech Startup Growth Hacking 101 - Basics on Growth Marketing
 
VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...
VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...
VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...
 
Call Girls In Panjim North Goa 9971646499 Genuine Service
Call Girls In Panjim North Goa 9971646499 Genuine ServiceCall Girls In Panjim North Goa 9971646499 Genuine Service
Call Girls In Panjim North Goa 9971646499 Genuine Service
 
Regression analysis: Simple Linear Regression Multiple Linear Regression
Regression analysis: Simple Linear Regression Multiple Linear RegressionRegression analysis: Simple Linear Regression Multiple Linear Regression
Regression analysis: Simple Linear Regression Multiple Linear Regression
 
Grateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdfGrateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdf
 
It will be International Nurses' Day on 12 May
It will be International Nurses' Day on 12 MayIt will be International Nurses' Day on 12 May
It will be International Nurses' Day on 12 May
 
BEST ✨ Call Girls In Indirapuram Ghaziabad ✔️ 9871031762 ✔️ Escorts Service...
BEST ✨ Call Girls In Indirapuram Ghaziabad ✔️ 9871031762 ✔️ Escorts Service...BEST ✨ Call Girls In Indirapuram Ghaziabad ✔️ 9871031762 ✔️ Escorts Service...
BEST ✨ Call Girls In Indirapuram Ghaziabad ✔️ 9871031762 ✔️ Escorts Service...
 
Nepali Escort Girl Kakori \ 9548273370 Indian Call Girls Service Lucknow ₹,9517
Nepali Escort Girl Kakori \ 9548273370 Indian Call Girls Service Lucknow ₹,9517Nepali Escort Girl Kakori \ 9548273370 Indian Call Girls Service Lucknow ₹,9517
Nepali Escort Girl Kakori \ 9548273370 Indian Call Girls Service Lucknow ₹,9517
 
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
 
Progress Report - Oracle Database Analyst Summit
Progress Report - Oracle Database Analyst SummitProgress Report - Oracle Database Analyst Summit
Progress Report - Oracle Database Analyst Summit
 
Best Basmati Rice Manufacturers in India
Best Basmati Rice Manufacturers in IndiaBest Basmati Rice Manufacturers in India
Best Basmati Rice Manufacturers in India
 

2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

  • 1.