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Complications of Biocompatibility Assessment in Absorbable Medical Devices
February 27, 2020 @ 11:00 am - 12:00 pm
The increasing diversity of medical devices means the lines between categories becomes less distinct and creating an appropriate risk management plan becomes more complex. Understand the challenges unique to absorbable devices (per ISO 10993-1:2018) and how to navigate the pre-testing process.
Discussion will cover:
- Brief historic perspective on absorbable devices
- Defining absorbable devices
- Sample preparation and extraction concerns
- Selecting an appropriate Predicate
- Overcoming challenges unique to absorbable devices