Risk Management is a fundamental part of a medical device’s technical documentation and conformity with the General Safety and Performance Requirements (GSPR) of both the MDR and IVDR. BioReg experts can assist you with risk management activities and documentation. We also provide a gap analysis for ISO 14971(2012) to ISO 14971(2019) requirements and compliance.
A Risk Management File will consist of at least the following:
- Risk Management Plan
- Risk Identification and Analysis
- Risk Management Report
BioReg experts can assist you with risk management activities and documentation.
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