4 – Validation, Pre + Clinical Evaluation2021-09-09T16:28:54+01:00

Clinical Evaluation

Implementing Master Validation Plans for devices & processes to meet;

  • FDA, EU MDR  / IVDR, UK MDR  & other national regulations;
  • Risk management in accordance with ISO 14971 standard;

Completing / reviewing pre-clinical and/or bench testing data and/or history of use for the clinical application to enable completion of Clinical Evaluation Plans / Reports,  PMS Plans / Reports and PMCF  / Trending Plans/ Reports

Coaching, co-ordinating pre-clinical, electrical, biological safety & performance testing, to 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 Plans & Report(s)

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

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