ORCA Annual Meeting
ORCA Members, Non-Members, and Guests are cordially invited to attend the virtual
2021 ORCA Annual Meeting
Please register by Monday, September 27th
Board of Directors Elections
Presentation by Daryl Wisdahl and Ken Pilgrim of EMERGO by UL
Small Group Virtual Networking
Raffle Draw (Present to Win)
Speakers: Daryl Wisdahl and Ken Pilgrim of EMERGO by UL
Topic: Post-market Surveillance
Topic Description: Post-market surveillance (PMS) is complex and often misunderstood by device manufacturers. Europe's new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), along with Health Canada’s recent amendments to their Medical Devices Regulations (CMDR), have added to the complexity of complying with PMS requirements. Many companies will need to update their PMS procedures and implement a more robust process for conducting PMS. This webinar will discuss the new PMS requirements and how to perform it.
Daryl Wisdahl has more than 25 years of experience in the medical device industry and specializes in Quality Management System (QMS) implementation and compliance, and regulatory submissions for medical devices. Daryl’s quality background includes: implementing quality management systems, QMS and supplier audits to FDA QSR, ISO 13485, In Vitro Diagnostics Directive and Regulation (IVDD and IVDR), Medical Devices Directive and Regulation (MDD and MDR), and MDSAP. Daryl’s regulatory background includes: 100+ Health Canada submissions and licenses, 15+ FDA 510(k) filings and clearances, 10+ European Technical File submissions, and FDA PMA Submission.
As a Senior Consultant, Daryl has reviewed Health Canada submissions, FDA submissions, and Technical Files for medical device manufacturers around the world. He assists with regulatory, quality, clinical and general business strategy development for medical device companies. Daryl joined Emergo as a consultant in 2005 and became Managing Director for Canada in 2010. Daryl relocated to Seattle, WA, in 2017, and presently supports manufacturers in the US, Canada and internationally.
Ken Pilgrim has over 20 years of industry experience at the Manager / Director level, overseeing corporate quality systems and providing input on business decisions and strategy, regulatory oversight, and risk management strategies for existing and new products. Ken specializes in regulatory submissions, including those for IVDs, implantable devices, and tissue products. His expertise includes international regulatory compliance such as MDR/IVDR support and strategy; 510(k) clearances and other FDA activities, such as Pre-Sub meetings and 513(g)s; Class II – IV Medical Device Licenses for Health Canada; EU Technical Files (MD / IVD); Risk Management files; and global regulatory strategy. Ken’s quality system background includes: implementing quality management systems (QMS) and supplier audits to FDA QSR, J-GMP, ISO 13485, and MDSAP.
Additionally, Ken oversees EMERGO by UL’s RA/QA Consulting activity in Canada. In this role, he has peer reviewed 100+ regulatory filings and reports.
When: Tuesday, September 28, 2021
8:00 to 10:00AM
Where: Online Meeting
Fees: No fees for Members, Non-members, and Guests
Please invite a colleague to learn about ORCA.
This webinar will be recorded.