To download the entire presentation, visit this link: http://resources.rqteam.com/iso-13485-webinar-slides-and-recording The world's most well known standards for medical device quality management have been updated for the first time since 2003. Released in March by the International Organization for Standardization, ISO 13485 provides the universal requirements for manufacturers and service providers to comply to regulatory requirements. The standards aim to establish consistent processes for medical device design, progression, installation and distribution, focusing on the safety of the total life span of the device. The standards must be adopted by 2019, which could prove to be a difficult task for manufacturers. Commencing adoption sooner rather than later will aid a steady transition... and that's why R&Q is hosting a free webinar. In this webinar R&Q's Director of Regulatory Affairs Nancy Morrison and Client Solutions Advisor Christine Santagate will walk you through 10 tips to adopt these changes. From conducting a gap assessment and creating a quality plan to modifying procedures/processes and auditing, our experts will communicate industry best practices so you can confidently take the next steps in YOUR process. We hope you join us for this free learning opportunity!

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1 0 T i p s f o r A d o p t i n g t h e U p d a t e d S t a n d a r d s

2. A B O U T R & Q
Regulatory and Quality Solutions (R&Q) is the industry leader in providing
regulatory and quality support to medical device companies.
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3. A B O U T T O D A Y ’ S S P E A K E R S
 20+ years of quality and
regulatory experience in
medical products industry
 US and global submissions and
quality system implementation
 Start-up, mid-size, and multi-
national companies
Nancy Morrison, RAC, Director of Regulatory Affairs
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4. A B O U T T O D A Y ’ S S P E A K E R S
 Focused on the product
development lifecycle
 CAPA and complaint systems,
design control processes, and
International approval
(510k, PMA, CE)
 Auditing quality systems against
ISO and QSR regulations
Christine Santagate, RAC, Client Solutions Advisor
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5. B R E A K I N G N E W S ! ! ! ! ! !
English Version of
Medical Device
Regulations
Available
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6. I S O 1 3 4 8 5 : 2 0 1 6 K E Y C H A N G E S 1
 Alignment of global regulatory requirements
 Inclusion of risk management and risk based decision making throughout the
quality management system
 Additional requirements and clarity with regard to validation, verification, and
design activities
 Strengthening of supplier control processes
 Increased focus regarding feedback mechanisms
 More explicit requirements for software validation for different applications
1 Reference: http://www.bsigroup.com/en-GB/medical-devices/our-services/ISO-13485-Revision
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7. 2 0 1 9 I S C L O S E R T H A N I T A P P E A R S …
CMDCAS → MDSAP
1/2019
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MDR/IVDR
~12/2019 ISO 13485:2016
3/2019ISO 13485
MDR
MDSAP

8. 1 0 S T E P S T O I M P L E M E N T A T I O N
1. Obtain the new standard and identify key changes
2. Conduct a gap assessment between current system and ISO 13485:2016
3. Form a team to address the gap assessment
4. Create a quality plan to address the gaps and get organizational buy-in
5. Charter sub-teams that will address each system that needs updated
6. Modify procedures/processes
7. Train employees
8. Internal audit or third party independent audit against the new standard
9. Schedule NB audit to update certification
10. Celebrate!
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