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.
Support Services
- 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
- EUÂ / UK Authorised Representative
- EU Device Regulations (MDR and IVDR)
- Technical Documentation
- EUÂ / UK declaration of conformity
- MHRA or Competent Authority Registration
- UDI, EUDAMED Registration
- National Applications / Registrations
Would you like to know more?
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