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Organization of Regulatory and Clinical Associates
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Organization of Regulatory and Clinical Associates
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HomeCurrent/Future Events2021 ORCA Annual Meeting and Keynote Presentation - Post-market Surveillance

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2021 ORCA Annual Meeting and Keynote Presentation - Post-market Surveillance

When:
Tuesday, September 28, 2021, 8:00 AM until 10:00 AM
Where:
Link will be emailed to attendees 2 days prior to the meeting, or the night prior if
registering closer to the event


Additional Info:
Category:
Annual and Social
Registration is closed
Payment In Full In Advance Only
RSVP by 6:00PM Monday, Sept 27, 2021

Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.
No Fee
No Fee
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
 

Introduction

ORCA Business:
Board of Directors Elections
Financial Reporting

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.
 
Speaker Biography:

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.