Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The FDA has focused efforts in supporting industry by providing the guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’” and the draft guidance “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin”.
This presentation will provide a practical approach to aid regulatory professionals drafting a biocompatibility risk assessment to use in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo requests for medical devices.
Member: $0 | Nonmember: $25
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Regulatory professionals in biologics, engineering, and medical devices.
Instructors:
Melissa PaffenrothSenior Regulatory Consultant
Melissa Paffenroth, PhD is a forward-thinking professional with 11+ years of success in regulatory affairs and 5+ years of success in research and development. She is experienced in medical devices and IVD medical devices.
As a Senior Regulatory Consultant, Melissa is an integral part of the MEDIcept team. She leverages her technical skill set into her regulatory work. Before joining MEDIcept, she was the Regulatory Manager at ZOLL Medical and ACE Surgical Supply Co., Inc., a subsidiary of Henry Schein. She also held regulatory positions at Waters Corporation and Smith & Nephew in the Endoscopy Division.
Meliss holds a Doctorate of Science in Biomedical Engineering and Biotechnology, Master of Science in Biomedical Engineering and Biotechnology and Bachelor of Science in Plastics Engineering from The University of Massachusetts Lowell.
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 raps@raps.org. RAPS is unable to accept cancellations by phone.
To transfer a registration, email raps@raps.org with the event title, name of the original registrant, and contact information for the new attendee.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-helpFor account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.