Auditing & Monitoring for Compliance and Improvement

With you we maintain and develop of your QMS and product certification with cost effective,  independent, thorough Auditing & Monitoring Processes to

  • Assess compliance with Regulations / Standards, your QMS and Technical Documentation and
  • Identify improvements and efficiencies.
Audit

Providing efficient, cost effective services using experienced, qualified Auditors who can;

  • Design, collate and maintain an efficient Auditing & Monitoring Schedule / Plan

  • Perform Internal Audit, Supplier, Contract Manufacturer, Fulfilment / Distribution audits at planned intervals or as stand-alone service, to monitor compliance and identify where improvements and efficiencies can be realised

  • Conduct monitoring of Post Market Surveillance, Vigilance, PMCF and Medical Device Reporting

  • Prepare Reports and as appropriate Corrective & Preventive Actions (CAPA)

C Li 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