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Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
PMCF is now an expectation for many medical devices. As the expectations for EU MDR become clear, PMCF can still be confusing. We will review what may qualify for PMCF, what is required, and when it is required.
A live Q&A portion with the speaker will follow the presentation.
This event is brought to you by the RAPS Ontario Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.
Enterprise Member: Free
RAPS Member: Free
Regulatory professionals and regulatory writers
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation.
RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.
Angela Siebeneck, MSN RN
Director, Regulatory Strategy and Policy at Synchrogenix, a Certara company
Mrs. Siebeneck has over 30 years of clinical and regulatory experience beginning her career as a registered nurse in a hospital setting. She has extensive experience in regulatory strategy, clinical, and medical writing. Her experience with regulatory approvals spans Europe, Australia, the United States, and Asia. She has authored or contributed to over 100 MEDDEV 2.7/1 Rev 4 compliant Clinical Evaluation Reports(CER), as well as post-market surveillance (PMS) plans/reports, post-market clinical follow up (PMCF) plans/reports, safety and performance evaluations, clinical study reports, human factors studies, and regulatory agency responses for medical devices. Additionally, she has experience with pharmaceutical labelling and submissions including Summary Product Characteristics (SmPC), Company Core Data Sheets (CCDS) and Orphan Drug Designations (ODD). Her clinical experience encompasses several areas including vascular access, orthopedics, interventional radiology, surgical intensive care, trauma, and home care.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to firstname.lastname@example.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
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Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org