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.

In 2025, Swissmedic ran a market surveillance campaign among Swiss importers of medical devices to verify compliance with the MedDO and IvDO. 57% of the importers had deficiencies. Swissmedic therefore intends to continue these inspections in 2026.

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
    • Joint planning of the Readiness Check.
    • Provision of preparatory documents.
  • Execution
    • Readi­ness Check, simulating a Swiss­medic in­spec­tion.
    • Review of documentation through interviews with relevant employees and assessment of key processes.
  • Follow-up
    • Final report with findings and prioritized recommendations for closing gaps.
    • Joint development of an action plan to remedy 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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Frequently Asked Questions about Swissmedic inspections

How will I know if my company is being inspected by Swissmedic?

If you have been selected by Swissmedic for this year’s priority action as part of the random sample, you will be notified separately by registered letter.

How much time do I have to prepare for an announced inspection?

If you receive a letter from Swissmedic, this will usually be around 30 days before the date of the inspection. However, you will be required to provide initial information within a week.

What do I need to consider when preparing for an inspection?

Before the inspection, Swissmedic requires that they confirm the date and location of the inspection and provide the name of a contact person responsible for ensuring compliance with the importer’s obligations. 

You must also be ready to provide a list of all medical devices and in vitro diagnostic medical devices that you import, including various details such as the risk class of the products.

Last, you should be familiar with Swissmedic’s guidelines. Visit our blog article for more information.

Swiss Medtech webinar replay: "Swiss importers, are you ready for Swissmedic inspections?"

Presentation Decomplix, download PDF

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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