Regulatory Strategy & Transition Planning

For new devices we support the definition of regulatory strategies and plans from proof of concept (POC) to market clearance in your chosen territory. With you, we plan device design & development, risk management, environment controls to meet ISO 14644, manufacturing / assembly, (including contract manufacturing), packaging & labelling / UDI, sterilisation, clinical evaluation, change / additions to regulatory applications / registrations and product launch & distribution.

For existing devices, we support manufacturers, distributors and other economic operators to establish effective MDD / IVDD to MDR / IVDR and CE & UKCA transition planning to address and meet the new  EU regulations (EU) 2017/745 (MDR) & 746 (IVDR), new UKMDR and new EN / ISO standards and/or common specifications.

Support extends to EU Notified Body and/or UK Approved Body selection, application and / or change, National Registrations such as  EUDAMED, MHRA and supporting non-uk manufacturers as their designated UKRP.

Providing expert resources to advise, develop, plan, implement best fit practices and controls for:

  • POC including technology application re: clinical need, indications for use and application

  • Specification development, definition, including User and Interface Requirements

  • Risk Management planning & identification of national and international standards for test

  • Notified Body Application / Change

  • Materials specifications & selection

  • Materials testing protocols including characterisation, biocompatibility, physical / mechanical / chemical  attributes

  • Clinical Evaluation

  • Specific country applications / clearances

  • PMS & Vigilance Planning

C L i 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