Frequently Asked Questions

  • We work with medical device and IVD manufacturers of all sizes — from early‑stage startups to global organizations — supporting Class I–III devices, IVDs, and combination products. Our services are tailored to your maturity level, regulatory pathway, and market strategy.

  • We support compliance with:

    • EU MDR (2017/745)

    • EU IVDR (2017/746)

    • ISO 13485:2016

    • ISO 14971:2019

    • FDA 21 CFR 820 / QMSR

    • MDSAP requirements

      We also assist with global submissions and regulatory strategy.

    • Senior expertise only — you work directly with a seasoned QA/RA leader, not junior consultants.

    • Deep regulatory mastery — MDR, IVDR, ISO 13485, ISO 14971, FDA QMSR, MDSAP.

    • Proven audit success — strong track record with Notified Bodies, FDA, and MDSAP.

    • Strategic + hands‑on — high‑level guidance combined with practical execution.

    • Tailored solutions — no templates; everything is customized to your product and pathway.

    • Clear, executive‑level communication — calm, structured, and reliable.

    • Global perspective — experience across Europe, the US, and Asia.

  • All client information is handled under strict confidentiality. NDAs can be signed upon request, and all data is processed in compliance with GDPR and Swiss FADP.

  • Yes. We assist with QMS alignment to QMSR and MDR, documentation readiness, audit preparation, and regulatory strategy and submission packages for EU and U.S. market entry.