Clinical Evaluation

Meeting Medical Device Regulation (EU) 2017/745 (MDR) & 746 (IVDR) and other national requirements, to provide Clinical Data that supports the medical device performance and safety claims.

Using our expertise we assist you review pre-clinical and/or bench studies, assess substantial equivalence, complete literature reviews, establish clinical protocols, clinical investigation / IDE applications, clinical investigations plans & reports in accordance with ISO 14155.

Evidencing medical device safety and clinical performance & completing Clinical Evaluation in compliance with EC, FDA and other national regulatory requirements.

Applying MEDDEV 2.7/1 revision 4 as a base we provide the necessary expertise to address the requirements of the MDR  / IVDR to develop, implement and complete:

  • Test Protocols to establish GSPR

  • Clinical Investigation Protocol(s) & Plans

  • Clinical investigation  / IDE applications

  • Clinical Investigation Report(s)

  • Clinical Evaluation Plan(s) & Report(s)

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

We provide training in Clinical Evaluation (See Training) and the necessary support thereafter.

C L i C for Support

Design / Develop D&D planning, user requirements, verification, validation & change. Risk Management Planning, hazard identification, risk control, benefit-risk analysis. Audit & Monitor Obtaining data to verify compliance: Improve product(s), plant(s), processes, people & controls. Services Technical Documentation Tech Doc collation to evidence safety & performance & meet national regulations. Change Control Controls & risk management of changes to device(s), processes, systems & Tech Documentation. Clinical Evaluation Clinical Evaluation planning, data review, reporting & updating. Services Data Analysis Practical, proven, efficient KPI's to identify, collate, analyse, act & improve products, processes & people. Doc & Data Control Efficient, reliable, traceable Doc & Data controls. Launch & Distribute Importer / Distributor QMS, agreements, traceability, controls and diligence. Services Management Systems Developing & maintaining effective, compliant QMS; improving product, resources, processes & organisation. NCR & CAPA Identifying, recording, analyzing, preventing & correcting product, process & system issues. Ops Management Effective compliant, efficient controls, (incl. outsourced processes). Services Performance Improvement Implementing improvement in your device life-cycle & compliance. Regs & Standards Identifying & meeting relevant regulations, common specifications & standards. Reg Strategy & Plan Regulatory strategies / plans for device development & clearance to market; FDA, CE, UKCA, UKNI. Services Reg Submission Preparing & collating data to reduce time for complaint submissions to gain clearance for product launch. Verification & Validation Planning, verifying, validating designs, processes, environ controls, equipment, products, plant & test methods. Vigilance & PMS Documenting & implementing PMS / PMCF plans, vigilance system & incident reporting. Services GPB - Design Control GPB - Risk Mangement GPB - Audit Monitoring GPB - Technical Documentation Change Control Clinical Evaluation Data Analysis Doc & Data Control Launch & Distribution Performance Improvement Regulation Standards Regulatory Standards Management Systems NCR & CAPA Operations Control Regulatory Submissions Verification & Validation Vigilance & Post Market