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:
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
Support Services
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