Clinical Evaluation Template

Clinical Evaluation Template

£160.00

All medical devices require a clinical evaluation and a clinical investigation in order to prove that the product is safe to be used by the intended users and that it achieves what the manufacturer claims the device was designed for, i.e. the device’s intended use.

A preview of the Clinical Evaluation Template is available here:

You may purchase the full document in convenient Microsoft Word format including instructions for use below.

Description

All medical devices require a clinical evaluation and a clinical investigation in order to prove that the product is safe to be used by the intended users and that it achieves what the manufacturer claims the device was designed for, i.e. the device’s intended use.

This template could be used in order to complete:

  • the clinical investigation plan
  • the clinical investigation report
  • the clinical investigation application form
  • the Investigator’s Brochure.

As per the requirements under the new EU Medical Device Regulation 2017/745

Our templates are developed with consultants who have over 20 years’ experience in the Medical Device industry and documentation that has been through successful audits.

Our consultants are available, should you need further assistance in completing the documentation.