ISO 13485:2016 - 10 Tips for Adopting the Updated Standards PREVIEW

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

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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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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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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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B R E A K I N G N E W S ! ! ! ! ! !

English Version of Medical Device

Regulations Available

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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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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

MDR/IVDR

~12/2019 ISO 13485:2016

3/2019ISO 13485

MDR

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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!