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.

Doctors performing surgery

Supporting you with valuable expertise to develop, implement and complete:

  • Test Protocols for materials and 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: