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Consultants & Auditors

Overview​

Regulatory affairs consultants and quality management auditors play an important supporting role in the Swiss medical device regulatory landscape. Unlike manufacturers, CH REPs, importers, or distributors, they are not defined as economic operators under MedDO — they carry no direct regulatory liability for the devices they advise on. Their role is to provide specialist expertise to manufacturers and CH REPs navigating MedDO/IVDO requirements.

What Regulatory Affairs Consultants Do in Switzerland​

Regulatory affairs (RA) consultants working in the Swiss medical device space typically provide:

  • Regulatory strategy — identifying the applicable regulatory pathway under MedDO or IVDO, assessing the impact of the MRA on market access, advising on CH REP requirements
  • Technical documentation — preparing or reviewing GSPR compliance matrices, risk management files, clinical evaluation reports, and Annex II/III documentation
  • Conformity assessment support — preparing NB submissions, managing NB interactions, responding to NB deficiency questions
  • Swissmedic registration — supporting DAPI notification and registration submissions on behalf of manufacturers or CH REPs
  • Vigilance and PMS — establishing or reviewing post-market surveillance systems, PSUR preparation, eVigilance reporting processes
  • Gap assessments — assessing an existing regulatory file against MedDO requirements, especially for legacy MDD-certified products requiring MedDO transition

What Quality Auditors Do​

Quality auditors with Swiss medical device expertise perform:

  • ISO 13485 internal audits — auditing QMS processes against ISO 13485:2016 requirements in the context of MedDO obligations
  • Pre-NB audit assessments — mock audits simulating an NB QMS audit to identify gaps before the official audit
  • Supplier audits — auditing critical suppliers on behalf of medical device manufacturers
  • Post-FSCA effectiveness audits — verifying that corrective actions have been effectively implemented

Key Swiss Regulatory Knowledge Areas​

Consultants and auditors working in Switzerland should have specific knowledge of:

  • MedDO and IVDO requirements (not just EU MDR/IVDR — while the technical requirements are identical, Swiss-specific procedural requirements apply)
  • DAPI registration and notification processes
  • CH REP obligations under MedDO Art. 56–59
  • Swissmedic eVigilance portal and Swiss vigilance reporting requirements
  • Swiss labelling requirements (DE/FR/IT)
  • Current CH–EU MRA operational status and its practical implications
  • ClinO-MD and BASEC processes for clinical investigations in Switzerland

Professional Associations​

  • RegAss — Swiss Regulatory Affairs Society (regas.ch)
  • RAPS — Regulatory Affairs Professionals Society (global, active in Switzerland)
  • Fasmed — Swiss trade association for medical technology companies
  • MedTech Switzerland — industry association

Official Sources​

Disclaimer

AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.