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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.
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