With new and changing standards, MDR, and an increase emphasis on chemical characterization, biocompatibility looks a lot different today than it did even three years ago. In this presentation Thor Rollins, Director of Toxicology and E&L Consulting, discusses what the FDA and notified bodies are asking regarding biocompatibility. He also discusses the following:
- The status of E&L, regulatory acceptance, and industry capacity.
- In-vitro alternatives and the new ISO 10993-23 standard.
- How using pre-subs have changed during the Coronavirus pandemic.
- The new draft of biocompatibility of skin contacting materials.