Management Systems

Unrivalled experience supporting you (re-) design, document, implement & maintain your EN ISO 13485:2016 Quality Management System to:

  • address, integrate and meet EC MDR & IVDR, CFR820 transition to ISO 13485, MDSAP and other national regulations / requirements / standards
  • ensure efficiencies in management, processes, personnel, materials / supply chain, operations and distribution to suit your business, services and products
  • reduce business and user / patient risk
  • provide the necessary data to enable market surveillance & vigilance
  • continually appraise and improve performance
  • maintain your systems certifications and clearances to market.

Incorporating & embracing specific country requirements such as:

  • The Medical Device Single Audit Program (MDSAP)

  • Japan MHLW Ordinance No. 169, (QMS Ordinance)

  • USA FDA CFR820 transition to ISO 13485

  • Brazilian Good Manufacturing (BGMP) Certification

  • China Good Manufacturing Practice for Medical Devices

  • Mexico GMP Requirements & Technovigilance

Improving people, products/services, user experience, processes & systems for business advantage. Supporting you drive, maintain & develop your QMS (see In-House Expertise) and deliver Training in Quality Systems including EN ISO 13485:2016, MDSAP and other National GMP Requirements.

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