THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
Watch now: Optimizing a QMS for medical device companies
Our Emergo by UL expert reviews various global QMS standards and regulations, including the MDSAP, and discusses key areas of impact.
Webinar date
July 30, 2024
Speaker
Ken Pilgrim, Manager, Quality Assurance/Regulatory Affairs Program
Ongoing global harmonization activities and the proliferation of statutory quality management system (QMS) requirements for regulatory compliance make it challenging for medical device and IVD companies to navigate.
This webinar will help you gain a better understanding of the decision points and strategies to consider when planning QMS upgrades to help your company comply with additional medical device market regulatory requirements.
Learning objectives
Review various global QMS standards and regulations, including the Medical Device Single Audit Program (MDSAP)
Key areas of impact
How to optimize a QMS structure to simplify the upgrade process and allow for more efficient future updates to include additional applicable requirements.
About the presenter
Ken Pilgrim, Manager, Quality Assurance/Regulatory Affairs Program
Ken Pilgrim oversees Emergo by UL’s RA/QA consulting activity for Canadian market compliance. In this role, he has submitted or peer-reviewed over 100 regulatory filings and reports.
Ken has been with Emergo by UL for over 11 years and has 25 additional years of industry experience at the manager/director level. He specializes in implementing and auditing quality management systems to ISO 13485, MDSAP and the EU MDR/IVDR requirements.
Ken also handles global regulatory submissions, including those for IVDs, medical software (including SaMD), implantable devices and tissue products.
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