Medical Device Technical Documentation

With you, preparing, completing, collating and maintaining your medical device Technical Documentation to evidence:

  • Intended Use
  • EC  / Country Classification
  • Predicate(s)  / Substantial equivalence
  • Risk Management
  • UDI / Labelling
  • Attainment of ISO / National Standards
  • Device safety & performance
  • Clinical Evaluation
  • Compliance with country specific regulations
  • Declarations of Conformity

Together we determine the risk category / profile and intended purpose of your medical devices to establish the feasibility of defining specific groups or categories of devices for which one Technical File may be possible for each group or category. We will prepare and collate compliant Technical Documentation to meet national regulations including:

  • EC Medical Device & IVD Regulation Annexes I, II and III Requirements

  • Device History File (DHF)

  • Device Master Record (DMR)

  • Risk Management File

  • Clinical Evaluation

  • Declarations / Statements of Conformity

  • Post Market Surveillance Plan

  • Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

In accordance with your Regulatory Strategy, and specific country  / national requirements we support you to successfully achieve the CE  / CA Mark, 510k Regulatory Clearance, Listing or Licensing as appropriate.

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