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Biocompatibility and Testing: Half-Day Workshop for Medical Device Manufacturing

Phillip G. Smiraldo, Ph.D., DABT (Toxicologist, NAMSA)

Amarjit “Al Luniwal, PhD, DABT (Toxicologist, NAMSA)

Location: 207A

Date: Tuesday, February 11

Time: 8:30am - 11:45am

Track: Sponsored Session

Vault Recording: TBD

Audience Level: All

  1. ISO 10993-18 2018 Updates: What Are The Relevant Changes And How It Impacts The Biocompatibility Safety Evaluation Process For Medical Device Manufacturers (60 Min Session)

Medical device organizations that manufacture products that involve patient contact are most often required to perform some level of chemical characterization evaluation, per ISO 10993-18, to ensure end-user safety. Depending on a device’s intended clinical use, chemical characterization – specifically, extractable/leachable testing – may be required by various regulatory agencies to address biological safety. However, utilizing this type of testing methodology to address various updates to medical devices can prove to be a cost-effective way to assess device changes and their potential impacts to biological safety.

With the anticipated issuance of ISO 10993-18, manufacturers are given further guidance and direction as to the use of material characterization and the implementation of testing for chemical entities. This session will highlight the main focus of the document and the top 10 items manufactures need to address immediately in the biological evaluation programs.


  1. Commercial Implications of a Properly Planned Biological Evaluation Strategy, Including the Use of Chemical Characterization (50 min)

Since 2009, the emphasis on a risk management process and characterization of materials continues to shift the biological safety paradigm. Put simply, the days of medical product manufacturers simply contracting with a testing laboratory, reviewing and accepting a recommended product evaluation plan is no longer a globally accepted practice.

Join this session to learn how a well planned strategy utilizing chemical characterization can have favorable and even cost saving implications for the commercialization of your product. This session will be a start to finish, step by step instruction on when to start your planning, what steps to follow to execute chemical characterization testing and/or biological testing, and how to keep your timelines as short or shorter than when performing conventional biological testing.


3. Open Question and Answer