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14.02.2018 Claudia

Decomplix’ first CE!

QS Zürich issued a CE mark for EXVASIN and NephroPatch to Decomplix this week. With this, we reached an important milestone: The CE certification outsourcing with Decomplix works! Decomplix is now a legal manufacturer.

About the customer and the product: The Vostra-Med Ltd. from Zug is led by an experienced MedTech team. It develops and distributes sterile silicone patches, also known as «External puncture closure devices» for nephrology, cardiology and radiology. The elastic strips are used to close blood vessel punctures after medical treatment. It is used as a substitute the manual or mechanical compression of punctures by the patient or nursing staff. It allows, for example, dialysis patients, who are obliged be treated several times a week in a hospital/practice to go home much faster which improves their quality of life significantly.

01.06.2017 @decomplix

As a digital healthcare leader, Denmark is troubled by tech disruptors. #medicalapps #wearables #data https://t.co/ocbseOtMwP

19.05.2017 @decomplix

Very proud of our buddys next door. Congrats! #medicaldevice #startup #SaMD https://t.co/HUZLSbv6MJ

19.05.2017 Claudia

Joint Venture augmented

Decomplix AG was founded in June 2016 as a joint venture between established companies and professionals. The mission is to accelerate innovation by shortening the time-to-market and simplifying market access for medical devices. The founders are Hansjörg Riedwyl & Partner of the Medtech service provider ISS AG, the innovation agency Creaholic SA, the law firm Beutler Künzi Stutz AG and Beni Hirt from the app business. The multidisciplinary team has been augmented with two partners: netrics AG

As a leading swiss managed service provider and cloud pioneer, netrics AG provides IT services from its own data centers in Switzerland in combination with public cloud offers. Decomplix can connect its client’s medical apps and wearables with cloud services from secure data centers from the ISO 27001 certified netrics AG.

19.05.2017 Claudia

Dear app developers

At the beginning of April the EU parliament adopted the new medical device regulation (MDR). And the new rules will be tougher. Barriers to market will significantly increase from 2020. Startups, SME’s and app developers are particularly affected. For example, classification-rule 11 will reclassify most class I software into a higher class: «Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa…». Suddenly, developers need a Notified Body and a certified quality management system to obtain their CE-certificate. This is a deal-breaker. Compared to other market solutions available, Decomplix offers its clients an advantage by taking over the responsibility for legally manufacturing the CE marking and to stay on the market.

19.05.2017 Claudia

Certified and ready!

Milestone 1 achieved: Decomplix is now officially ISO 13485 certified meaning we have the certified quality management system required to be a legal manufacturer.  Decomplix is now ready to take on innovative developers and new entrants to bring their medical device faster to the CE market. Our clients can then focus on their business development, innovation and marketing.

Decomplix simplifies market access, in particular for medical apps and wearables, by shortening time-to-market substantially.