Technical files and
risk Management

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. Our services include:


  • 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

To contact a quality assurance expert at MCRA, call 202.552.5800 or email

MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services

People & Expertise



Quality Assurance

Mr. Biggins has over twenty years of experience in the area of Quality Systems and Manufacturing beginning as a Quality Engineering Manager. Mr. Biggins is an expert at Quality Management Systems, specifically in the areas of Corrective and Preventive Action (CAPA), Customer Complaints, Design Control Read More

PH: 202.552.5800