We combine our risk management expertise with your product expertise to ensure that technical regulatory submissions withstand new scrutiny for potential hazards by regulatory bodies.
Ensuring Compliance for Technical Files & Risk Management
Medical device manufacturers must navigate obstacles to demonstrate conformity assessment, which is an important part of quality assurance requirements. Technical file formats vary, but there are key parts and requirements that must be met to avoid violating compliance standards. MCRA’s experts have the knowledge and experience to make sure you are fully compliant.
- Create/review risk management plans
- Create/review risk management files (DFMEA, PFMEA, FMEA)
- Create/review essential requirements (ER) checklists, - which are required for the CE Mark
- Create/review technical files for class IIa and IIb medical devices in the EEA
- Create/review design dossiers for class III medical devices in the EEA
FDA requires proof of compliance with established design control procedures during the product design and development phase. Medical device manufacturers need to maintain records known as Design History Files (DHFs) documenting compliance with established design control procedures, and to have them ready for regulatory inspection once they obtain market authorization for their medical device. MCRA’s experts can show you how to properly create and maintain a DHF to ensure a more efficient quality assurance down the line.
- Design History File (DHF) reviews and remediation
- Implementation of design control process
- Facilitation of design review meetings