3 – Validation, Pre + Clinical Evaluation2018-03-14T14:55:03+00:00

Clinical Evaluation

Essential requirements to meet Medical Device Regulation (EU) 2017/745 & 746 requirements is the provision of current Clinical Data that supports the performance and safety claims made by the Manufacturer. GPB can assist with the review of pre-clinical and/or bench studies, Clinical Application and Clinical Evaluation.

Doctors performing surgery

GPB provides valuable expertise in assisting each client develop, implement and complete:

  • Test Protocols

  • Preparing & submitting investigation applications

  • Clinical Protocol(s) and Clinical Investigation Plans

  • Clinical Investigation Report(s)

  • Clinical Evaluation Report(s)

  • Post Market Clinical Follow Up (PMCF) and Trend Reports

  • Standard Operating Procedures
  • Standards and Regulations
  • Master Validation Planning
  • Clinical Evaluation Planning
  • Clinical Investigation Planning
  • Clinical Validation
  • Clinical Protocol(s)
  • Clinical Investigation Report(s)
  • Clinical Evaluation Report(s)
  • Post Market Clinical Follow Up (PMCF) Plan
  • Technical Documentation
  • Audit and Monitoring

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: