4 – Validation, Pre + Clinical Evaluation2019-08-01T19:38:00+00:00

Clinical Evaluation

Supporting you implement Master Validation Plans for your device design validations to meet Medical Device Regulation (EU) 2017 /745 (MDR) and /746 (IVDR) embracing risk management and clinical evaluation(s) to support your device performance and safety claims. Together we review pre-clinical and/or bench testing data and/or history of use for the clinical application to  complete the Risk Management, Clinical Evaluation Report(s) and PMCF Plans.

With valuable expertise in auditing, training, coaching, co-ordinating pre-clinical biological safety and performance testing, together we develop, implement and complete:

  • Test Protocols for materials to meet ISO 10993, design verification, safety and performance.

  • Clinical Protocol(s) and Clinical Investigation Plans

  • Clinical investigation applications to meet ISO 14155 and IDE

  • 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 commit to respond promptly to enquiry; please complete the contact form or contact us on one of the following: