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NAMSA

Don Pohl, BS

Principal Product Development Strategist

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Don has been with NAMSA since 1993, working in a variety of roles involving the biocompatibility evaluation of medical devices. Don’s expertise is specialised in preparing strategies to address biocompatibility issues using chemical characterization data, preclinical test results, in-vitro/in-vivo biocompatibility test data, toxicological risk assessment and relevant clinical data as described in ISO 10993-1, FDA guidance and other relevant regional and international standards. He has led dozens of trainings on behalf of NAMSA and plays an active role in NAMSA’s biocompatibility-focused podcast.

CORE COMPETENCIES

  • Addressing issues involving the biocompatibility assessment of medical devices, including new devices and changes to existing devices
  • Working knowledge of the U.S. Food and Drug Administration (FDA), EU Medical Device Regulation (MDR) and other global medical device regulations and all parts of the ISO 10993 series
  • Developing gap assessments, risk assessments, evaluation plans and strategy documents to support the biocompatibility evaluation of devices
  • Providing advice to Sponsors to support responses to FDA, Notified Bodies, Competent Authorities, NMPA and other global regulatory agencies
  • Assisting in the development of pre-submission documents for the FDA with plans to address biocompatibility for various types of final submissions (e.g., IDE, PMA, 510(k), EFS, etc.)
  • Presenting globally on biocompatibility and the ISO 10993 series, MDR and other vertical biocompatibility standards
  • Co-hosting NAMSA’s podcast, BioCompCHATibility

 RECENT PROJECTS

  • Provided virtual training for Sponsors on the basics of biocompatibility and the biocompatibility of packaging for medical devices
  • Provided feedback to numerous FDA comments regarding a PMA submission
  • Prepared several biological evaluation plans for the support of numerous 510(k)s and IDEs