Clearance to Market

Preparing, collating, reviewing, submitting and maintaining Technical Documentation to evidence safety & performance to meet national registration requirements such as EU (MDR, IVDR) CE mark, EUDAMED registration; MDSAP; US 510k application, UK Medical Device Regulations UKCA, UKNI mark and MHRA registration.

Acting as your designated UKRP for non-UK based manufacturers.

Preparing, compiling relevant safety & clinical performance data for your Technical Documentation / Device Files including Design and specification, Risk Management File, Clinical Evaluation, PMS Reports including:

  • Selection and Liaison with UK Approved Body and/or EU Notified Body where required

  • EU Medical Device (MDR) & IVD Regulation (IVDR) Annexes I, II and III Requirements and EUDAMED registration

  • UK Medical Device Regulations including UKCA, UKRP and MHRA Registration

  • Clinical Evaluation Plan(s) and Report(s) and PMCF

  • Risk Management Plan and Report.

  • Summary Technical Documentation as (STED)

  • Post Market Surveillance Plan, Post Market Clinical Vigilance / Reports, Feedback data analysis and Reporting.

  • Declarations to EU Harmonised  or National Standards with Statements of Conformity

  • Regulatory applications, notifications, submissions to regulatory authorities & registratons

Meeting specific national requirements, to successfully achieve national clearances, registrations, listings, or licensing as appropriate to your chosen territory.

  • Standard Operating Procedures
  • ISO 13485, 14971, CFR 820, device classification
  • ISO, AAMI, ANSI, EN, IEC Standards
  • CE, UKCA, UKNI
  • EUDAMED / MHRA Registrations / Listings
  • Economic Operator Registrations
  • EU  / UK Authorised Representative
  • EU Device Regulations (MDR and IVDR)
  • Technical Documentation
  • EU  / UK declaration of conformity
  • MHRA or Competent Authority Registration
  • UDI, EUDAMED Registration
  • National Applications / Registrations

Would you like to know more?

    We commit to respond promptly; please complete the enquiry form or contact us on one of the following:

    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