Verification & Validation

As part of and/or in addition to Design Control aspects GPB provide support to you to design, implement, complete and maintain Master Verification and Validation Plans & File(s), Protocols & Test data.

This can include changes / modifications for:

  • Software

    • Stand Alone
    • Embedded / part of device

  • Materials / Devices:

    • Biocompatibility Assessment & Testing to ISO 10993 Series
    • Electrical Safety to IEC 60601 Series
    • Packaging to ISO 11607 Series
    • Stability / Lifetime & Shelf-Life determination to ISO 23640 including accelerated to ASTM F1980 and real time studies as appropriate
    • Handling / Transport

  • Process Validation embracing:

    • Process Definition & Control
    • Formulation
    • Molding
    • Coating / Bonding
    • Manufacture / Assembly
    • Packaging / Sealing
    • Sterilisation, including Ethylene Oxide to ISO 11135, Radiation to ISO 11137, Moist Heat to 17665 and other methods such as Liquid Chemical Sterilisation and Vaporized Hydrogen Peroxide (VHP)
Get In Touch

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