Clearance to Market

Preparing, collating, reviewing, completing, submitting and maintaining Technical Documentation to evidence safety & performance in compliance with national requirements such as EC (MDR, IVDR) CE, Canada (CMDR), MDSAP, US 510k, UK Medical Device Regulations UKCA, UKNI.

Acting as your designated UKRP for UK, completing EUDAMED, MHRA, FDA & other country manufacturer and device registrations

Preparing, compiling relevant safety & clinical performance data for your Design History File(s) (DHF), Risk Management File, Technical Documentation, Design Dossier(s) and Design Master Record(s) (DMR) including:

  • Selection and Liaison with Notified Body

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

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

  • Risk Management File (RMF)

  • Summary Technical Documentation as (STED)

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

  • Declarations / Statements of Conformity

  • Regulatory applications, notifications and submissions to regulatory authorities

Meeting specific national requirements, to successfully achieve CE, UKCA,  UKNI, and other national clearance, listing 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

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