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FMMC South Florida Briefing: Are You Ready for ISO 13485:2016?
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FMMC South Florida Briefing:  Are You Ready for ISO 13485:2016?

When: November 2, 2017
Where: Research Park @ Florida Atlantic University
3651 FAU Boulevard
Suite 400
Boca Raton, Florida  33431
United States
Contact: FMMC

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Are You Ready for ISO 13485:2016 and the Impact of MDR/MDSAP on Your Business?


The new ISO 13485:2016 standard requires important changes and updates to your Quality Management System, and is a cornerstone of the new European Medical Devices Regulation (MDR) and Medical Device Single Audit Program (MDSAP). With the introduction of new and more extensive requirements, medical device manufacturers are facing significant impacts on how they maintain certifications going forward. This important session will focus on ISO 13485:2016 timelines and primary changes, and show how the new Standard dovetails into the MDR and MDSAP. Find out some of the key things you will need to do to comply with the varying implementation timelines, with the first being January 2019 for Canada.

Session Topics:
ISO 13485:2016 – primary changes
Risk Management relationship
Transition periods
Relationship with MDR; primary MDR considerations
Relationship with MDSAP; primary MDSAP considerations


Our Speaker:

Linda Chatwin, Esq, RAC
Sr. Customer Solutions Consultant
EMERGO, a UL company
Customer Solutions Division



Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the global regulatory maze required to bring products to market, through years of watching regulations evolve and change. She holds a Regulatory Affairs Certification and is an attorney in the U.S. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. She has navigated many FDA inspections, and has negotiated favorable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, performing mock audits, in-depth training on regulatory requirements and consulting on quality system development and improvement.

Areas of regulatory expertise:
· Developing international regulatory strategy
· US FDA 510(k) and other regulatory submissions
· Remediation efforts from audit findings
· Quality system construction and improvement
· Training to QSR, Risk management, RoHS and safety standards
· Intimate knowledge of IEC 60601 standards, particularly 3rd edition including successful conversion of multiple product    families.
· Risk management file construction and maintenance
· Gap assessments to various certification standards
· Performing FDA Mock Audit and other outside auditing
· Managing FDA inspections
· Developing, implementing and mitigating design control processes
· Analysis and strategy development for MDR implementation


Thank you to our host!  

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