Decomplix

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Decomplix

The regulation, handled, so the device can ship

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Challenge

A medical device is not finished when it works. Europe's MDR and IVDR turned market access into a project in its own right - technical documentation, clinical evaluation, a certified quality system, a notified body queue - and Switzerland's exit from mutual recognition added another layer: a Swiss manufacturer is now a third-country manufacturer in the EU's eyes, and a foreign manufacturer needs a Swiss Authorised Representative before it can sell here at all. For a startup with a working device, that is a wall. For a large manufacturer it is a standing cost.

The part of a medical device that is not the device

Solution

Decomplix was founded in 2016 as a joint venture that Creaholic co-founded, to do the regulatory half of getting a medical device to market - the half an invention house keeps running into at the end of every medtech project. It takes on CE marking under MDR and IVDR, technical documentation, quality management, importer compliance and Swissmedic inspection readiness, and it acts as Swiss Authorised Representative for manufacturers outside Switzerland. With Evidencio it also runs a route for turning a clinical algorithm into CE-certified medical device software in under a year.

  • Technical documentation, clinical evaluation, quality management
  • Most of the work is advisory: deciding what the file actually has to prove

Results

More than a hundred companies use it, from startups through to large manufacturers - SD Biosensor, Immucor, Orkla, Groupe Mutuel, Oviva, GBO Medizintechnik and Balgrist University Hospital among them. It is based in Bern, and its usefulness is easy to state: it is the reason a device that works also gets sold, and the reason a Creaholic medtech project does not stop at the prototype.

Decomplix, Bern

At a glance

Founded
2016 · joint venture co-founded by Creaholic · Bern
Scope
EU MDR · IVDR · Swiss Authorised Representative (CH-REP) · importer compliance
Clients
100+ companies, from startups to large manufacturers
Also
Clinical algorithm to CE-certified software in under a year, with Evidencio

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