SOCRA 18th Annual Device Research & Regulatory Conference
Talk
The ODD couple: Clinical Risk Management via ISO 14155 and ISO 14971
Thu, Apr 24, 2025 · 8:40–9:40 AM PDT Hyatt Regency Newport Beach
About this session
The integration of device engineering risk concepts into clinical trial risk management activities is advancing at a fast clip. In addition, the identification of pre-defined and pre-quantified safety and performance acceptance criteria has become a required step in clinical evaluations. Putting these concepts together in the work required for clinical trials is new territory for us to explore together.
Speaker
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President and CEO · Frestedt Inc.
Speaker