Preparing, collating, reviewing, completing, submitting and maintaining your Technical Documentation to evidence compliance with national requirements such as EC (MDR, IVDR), UK Medical Device Regulations, Canada (CMDR), MDSAP, US 510k.
Preparing, compiling relevant data for your Design History File(s) (DHF) 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
Implementing your regulatory strategy to meet specific national requirements, to successfully achieve the CE and/or CA Mark, obtain 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 Marking / CA Marking / 510k
- Device 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