Technical Documentation (EU / FDA / MDSAP)

A regulatory compliant Technical Documentation (often referred to as Technical File) is a prerequisite for all medical device approvals and audits of Quality Management Systems (QMS). The term refers to the complete set of documents that a medical device manufacturer must submit to Regulatory and/or Auditing Authorities and is a requirement for most types of conformity assessments around the world.

Publication of the new Medical Device Regulation (MDR) has considerably increased requirements with respect to Technical Documentation submitted to European Authorities, which must now be structured as per Annexes II & III. On the other hand, Technical Documentation for MDSAP audits mainly focuses on QMS aspects and not on the assessment of a device’s safety and performance.

Evnia is providing a full spectrum of services to cover key areas of technical documentation:

Whether looking for a STED format or a customized structure, Evnia is providing a full spectrum of services to cover key areas of Technical Documentation such as:

  • Preclinical Testing
  • Verification and Validation Testing (including Process Validation)
  • Usability Engineering Testing Biological Evaluation Plans and Reports as per ISO 10993 (in conjunction with ISO 14971 and EU-MDR requirements where applicable)
  • Risk Management Files including planning, Risk Analysis, Risk Evaluation, Risk Control, Evaluation of Risk Acceptability and final Risk Management Report as per ISO 14971, AAMI TIR97, 21 CFR Part 820, Annex I (Chpt I; Section 3) of EU-MDR, MDSAP QMS P0005 (whichever is applicable)
  • Clinical testing
  • Clinical Evaluation Reports (EU) or Premarket Approval (PMA) Annual Reports (US)
  • Post-Market Surveillance including analysis of complaints and adverse events, Trend Reporting, CAPAs, PSURs, PMCFs and correlation with Risk Management (if and where applicable)

Contact us today by going to our contact page or call us at +45 88 82 57 97 to evaluate your needs towards achieving regulatory compliance.