5 – Regulatory Submissions & Approvals2018-03-14T16:06:29+00:00

Technical Documentation

GPB provide assistance in completing, collating and maintaining your Technical Documentation, to a defined structure, for your Product, Group or Family to meet specific country requirements and embrace as appropriate.

Small documents

We can assist with any aspect of Technical Documentation, 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 the Regulatory Strategy, and specific Country requirements we identify, collate, prepare and submit the documentation necessary to successfully achieve the CE Mark, Regulatory Clearance, Listing or Licensing as appropriate.

  • Standard Operating Procedures
  • QMS Certification
  • Regulations and Standards
  • CE Marking
  • Device Registrations
  • Economic Operator Registrations
  • EC Authorised Representative
  • EC Medical Device Regulation (MDR and IVDR)
  • Technical Documentation
  • EU declaration of conformity
  • MHRA or Competent Authority Registration
  • EUDAMED Registration
  • Other Country Applications

Would you like to know more?

We are here to help  you with any enquiries you may have, if you would like to speak to a member of staff, please fill out the following contact form or feel free to contact us on one of the following: