MCRA's experts have the knowledge and experience to make sure you are fully compliant.
Services We Offer
- Create/review risk management plan
- Create/review risk management files (DFMEA, PFMEA, FMEA)
- Create/review essential requirements (ER) checklist - required for CE Mark
- Create/review technical file for class IIa and IIb medical devices in EEA
- Create/review design dossier for class III medical devices in EEA
Our Integrated Approach
Medical device manufacturers must navigate obstacles to demonstrate conformity assessment, which is an important part of quality assurance requirements. Technical files’ formats are subjective, but there are key parts and requirements that must be met or risk violating compliance standards. MCRA’s experts have the knowledge and experience to make sure you are fully compliant.
