DC/ Baltimore Chapter Webcast: Conducting a Biocompatibility Risk Assessment for a Submission

RAC Credits
Chapter EventsChapter Events
Tuesday, 09 May 2023 (12:00 PM) - Tuesday, 09 May 2023 (1:00 PM) Eastern Time (US & Canada)

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‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’” and the draft guidance “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin”.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

At the conclusion of this workshop, participants should:

  • Have the tools necessary to understand the medical device categorization process by nature of body contact
  • Know how to document a biocompatibility risk assessment for medical devices
  • Understand options for impact assessments throughout the lifecycle of the device

Audience Learning Level

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.

Who Should Attend?

Regulatory professionals in biologics, engineering, and medical devices.


Melissa Paffenroth

Melissa Paffenroth
Senior 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.

Proof of Attendance

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 workshophttps://www.raps.org/website/virtual-event-help

For 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.

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