We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.
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.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.