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Jul 30, 2024
  • Webinar

Optimizing a QMS for Medical Device Companies

Learn more about how to optimize a quality management system to meet medical device regulatory requirements.

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Date & Time

Starts

Jul 30, 2024 9:00am CST

Ends

9:45am CST

Location

Online

Language

English

Ongoing global harmonization activities and proliferation of statutory quality management system (QMS) requirements for regulatory compliance are a tough terrain for medical device and IVD companies to navigate, Our webinar will help attendees develop a greater 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.

The presenter will review various global QMS standards and regulations, including the Medical Device Single Audit Program (MDSAP), discuss key areas of impact and offer recommendations on 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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