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

Support Services

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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