Areas of Operation – US, EU & UK

USA

  • 510k Preparation & Submission
  • Predicate Device Identification
  • Q Submissions/ Pre Submissions
  • De Novo Applications
  • 513g Classification Requests
  • Breakthrough Designation
  • PMA
  • IDE & Pre IDE
  • Manufacturing site registration & device listing

Quality & Management systems design, development, implementation and maintenance to:

  • ISO 13485 Quality System
  • MDSAP
  • QSRs (Part 820)
  • ISO 9001

Europe and the UK

  • MDR (EU) 2017/745
  • IVDR (EU) 2017/74
  • EU Authorised Representative
  • UK Responsible Person

Preparation of CE Marking Technical File / Design Dossier:

  • Technical and Design File Reviews
  • Risk Management Files
  • Medical Device/IVD classification
  • EU Authorised Representative
  • Product Risk Assessment
  • Post Market Surveillance and Reporting

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