IME West | February 7-9, 2023 | Anaheim Convention Center, Anaheim, CA


The Biological Evaluation of Medical Devices — Choose your Adventure

Tuesday, February 7th from 1–5 p.m. PST
Location: Room 204B

NAMSA will present a half-day training focused on the biological evaluation of medical devices: “The Biological Evaluation of Medical Devices—Choose your Adventure.” Led by a qualified instructor, attendees will choose their own adventure for medical devices through the evaluation process

Presented will be information on two different devices and device pathways to regulatory acceptance focused on biological evaluation. During this time, attendees will provide input and choose an intended path, by device, based on which will yield regulatory acceptance. Key focal points of this adventure will be challenges faced by varying regulatory authorities, ISO 10993–1, 10993–18 and 10993–17, just to name a few.

Audience
This session is ideal for professionals with a basic understanding of the biological evaluation of medical devices and wish to further learn how an experienced leader would evaluate different devices for biological safety. For the less experienced attendees, we recommend a thorough review of any available webinars as well as reading of ISO 10993–1, 10993–18 and 10993–17 to better understand the process of the biological evaluation of medical devices.

Attendees of this session will:

  • Evaluate various details of what is known about materials and device histories to help outline biological evaluation plans
  • Demonstrate different paths to regulatory submission
  • Overcome challenges that may be presented by different regulatory agencies

Instructor:

Don Pohl
Don Pohl
Principal Product Development Strategist, NAMSA

Don holds a Bachelor’s degree from Ohio State University and has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.

 


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