Get ready for your
Swissmedic inspection

Book a video call to discuss your needs and questions,
or request a quote right away.

Our Readiness Check gives you certainty and helps you avoid unpleasant surprises.

Swissmedic will inspect Swiss importers of medical devices in 2025 to verify compliance with the MedDO and IvDO.

For many importers, the obligations like product conformity verification, storage and transport conditions, traceability, and complaint handling are a challenge.

Don’t risk business disruption. Decomplix helps you prepare – pragmatically and efficiently.

100+ customers trust Decomplix

Our offer: Readiness Check for Swissmedic inspection

Based on our experience and expertise, we offer a pragmatic Readiness Check at a fixed price that prepares you specifically for a Swissmedic inspection. Our structured approach includes:

  • Planning
    • Definition of in­spec­tion ob­jec­tives follow­ing re­gu­la­tory re­quire­ments.
    • Provision of a case-spe­cific check­list.
    • Clarification of respon­si­bi­lities within your team.
  • Preparation
    • Review of rele­vant do­cu­men­tation (SOPs, records) for com­plete­ness and com­pliance.
    • Feedback on your do­cu­men­tation.
  • Execution
    • Readi­ness Check, simulating a Swiss­medic in­spec­tion.
    • Review of com­pliance evi­dence in con­text through inter­views with re­le­vant em­ployees, and assess­ment of key pro­cesses.
  • Follow-up
    • Detailed final re­port with fin­dings and prio­ri­tized re­commen­da­tions for address­ing gaps.
    • Joint deve­lop­ment of an action plan to prag­ma­ti­cally address non-con­for­mi­ties.

We also offer optional template packages for your quality management and ongoing support (regulatory monitoring, effectiveness checks, on-demand support). Learn more about our services.

Why Decomplix as your partner

  • Experience: Our experts have extensive knowledge of Swiss regulations (MedDO/IvDO).

  • Practical: We offer pragmatic solutions and actionable recommendations.

  • Efficient: Our structured approach saves you time and resources.

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Contact Person

Portrait Beni Hirt

Beni Hirt

Customer Relations & CEO

Beni Hirt has over 15 years of experience in customer relations and project management, particularly in software and business modeling. Beni Hirt builds and maintains partnerships with start-ups, SME, and big entities and supports them to clear regulatory hurdles and shorten the time to market. He is a business administrator and experienced in establishing and running new businesses and models. He also has co-founded and ran one of the most successful Swiss app agencies.

Contact

beni@decomplix.com
+41 79 668 02 60