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Risk Management in Biocompatibility Testing
September 5, 2019 @ 11:00 am - 12:00 pm
With the ever increasing requirements in medical device regulations about risk management, considering all potential options in your biological evaluation plan (see ISO 10993-1: 2018) can help identify potential hazards in biocompatibility testing as well as determining a path forward when positive results are observed.
Discussed will be:
- Sample preparation considerations and post-extraction changes
- Common positive results, their causes and how to mitigate the findings
- A positive result isn’t always an adverse one
- How to test liquids, creams and gels