CE-certified
medical device software

Get cost-efficient, and scalable market access for your medical software algorithm in less than a year.

Anyone who develops a software algorithm and aims to sell it as medical device software (MDSW) has to undergo CE marking. For most software, this entails a conformity assessment with a Notified Body that audits your company’s Quality Management System and the technical documentation of your product. This is a long, expensive, and laborious path. Making a careful decision about the regulatory strategy is key.

Decomplix, with its partner platform Evidencio, can offer a fast, proven, de-risked solution. The prerequisite is that your software fits with the platform’s scheme.

Decomplix’ Software Algorithm CE Marking service brings you high value:

We shorten your time to market: You get your market access in 9-12 months, in some cases even less than 3 months.
We minimize your liabilities and risks: Safeguarded by Decomplix and Evidencio, you minimize product liability risks, remaining in control and ownership of your specific IP.
After onboarding to the Evidencio SaaS platform and compiling the necessary documentation, your clinically validated algorithm is added as another medical device software product to the existing EU certificate without an exhaustive certification audit with a notified body.

You can join a compliant and scalable platform: Decomplix and Evidencio become your professional compliance solution along the entire product lifecycle.
We plug and play your algorithm into your customers’ clinical use environment leveraging the Evidencio platform with a proven compliant and highly scalable reference architecture and deployment model.
You benefit from a large network of experts and key opinion leaders in the clinical decision support/medical algorithms field. Decomplix is part of a leading innovation ecosystem, the Swiss Institute for Translational and Entrepreneurial Medicine in Switzerland, based at the University Hospital Campus in Bern.

We offer expert opinions, and specific input with rapid feedback that saves you time in your project and ensures your leadership in the market. Of course, we provide you with the necessary knowledge for all questions for development and successful certification.

Our support is structured in a modular manner to best suit your needs at your own pace. In any case, we perform a pre-assessment of your algorithm, its math, implementation, intended purpose, and clinical evidence to clarify if your project fits with the Evidencio platform and what to consider for the development of the needed technical documentation and software implementation under Evidencio’s QMS. Read more in this blog article.

Transforming an algorithm has multiple meanings

Transform to compliance: CE-certify your algorithm and stay compliant with Evidencio as your legal manufacturer.

Transform to business: Access hospitals, health care professionals, and EMR-integrations to realize your algorithm’s business case with the support and means of Decomplix and Evidencio international network.

Transform to scalability: Validate and scale your algorithm through services connected with the Evidencio SaaS platform and library.

Transform to product: Publish your algorithm on the Evidencio marketplace with +4000 algorithms.

We provide you with the necessary knowledge for all questions for development and successful certification.

How long does algorithm CE certification take?

We perform a 2-step process:

1. Starting with a pre-assessment, normally taking 4-6 weeks:

Software: algorithm, its math, technology stack, implementation, etc. for compatibility with the Evidencio platform
Intended purpose: medical claims, intended users, etc.
Clinical evidence: availability and quality of clinical data, and to which extent it covers the medical claims made in the device’s intended purpose description. This is often the most challenging part.

The pre-assessment produces a report which, if positive, is subsequently used to plan all following steps (which are technical documentation, clinical evaluation, algorithm onboarding, etc.).

2. Suppose the algorithm fits the fast track, the CE mark is typically obtained within 6-9 months.

Transform an AI algorithm into medical device software?

Yes, indeed, this is under the regulatory requirements like for other medical device software and additionally under the EU AI Act. Read more about AI Medical Device Software under EU MDR & IVDR.

Contact us

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
+4179 668 02 60

Why Decomplix as your partner?

100+ medical device and in-vitro diagnostic companies of all shapes and sizes trust Decomplix — from startups to corporates, from Switzerland to all around the globe.
Decomplix’ high level of compliance and regulatory knowledge was confirmed by a successful Swissmedic inspection in 2022. Decomplix is one of the few inspected CH-REPs without any non-conformities.

Decomplix operates under a ISO 13485 certified quality management system.
Decomplix’ customers benefit from easy-to-use digital tools with secure and compliant IT infrastructure.
Decomplix stands by as a coach in compliance matters and as the customer’s close contact to Swiss authorities.

Dr. Corina Matzdorf ulrich GmbH & Co. KG, Germany

«Being a German high-quality manufacturer for medical devices with more than 110 years of experience and operating worldwide, we feel very safe with Decomplix.»

Dominik Gutzler CytoSorbents Europe GmbH, Germany

«Decomplix as CH-REP is our partner of choice, providing us with a great comprehensive service and allowing us to focus our internal resources on other projects.»

Eric Tscharner HASA OPTIX, Belgium

«As a premium manufacturer of ophthalmic instruments, we feel very secure with Decomplix.»

Renate Reiss Neodynamics AB, Sweden

«Due to service quality, regulatory knowledge, and reliability, we can highly recommend Decomplix as CH-REP.»

Susanne Vesterinen RFSU AB, Sweden

«It feels very good to have Decomplix as CH-REP.»

Benjamin Schlenker Canvys – Visual Technology Solutions, Germany

«With Decomplix as our CH-REP and partner, we feel well-supported. The collaboration is exceptionally professional and efficient.»

Claudia Handler CARE diagnostica, Austria

«We appreciate the clear procedure, the professional approach, and the uncomplicated cooperation and highly recommend Decomplix as a business partner.»

Alain Kamm Sanitas Health Insurance, Switzerland

«For our digital health initiatives, we feel we are in safe hands with Decomplix.»

Florian Schulz OBERON GmbH Fiber Technologies, Germany

«Decomplix offers a professional approach and streamlined process for compliance and specific requirements of the Swiss market.»

Interview with Sang-Il Kim about the SwissCovid App

Interview with Sang-Il Kim about SwissCovid with Decomplix

Jonas Widmer Balgrist University Hospital, Switzerland

«With the regulatory evaluation of our planning software, we were able to take key steps in product development with Decomplix.»

José Näf nahtlos GmbH, Switzerland

«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»

Manuel Baumann Oviva AG, Switzerland

«We benefited tremendously from Decomplix's experience and expertise in working with the Swiss authority, Swissmedic, and with Notified Bodies.»

Markus Piller Medid AG, Switzerland

«The flexibility, broad-based expertise and the will to always find a suitable solution for our problems as a small MedTech company are qualities we greatly appreciate about Decomplix.»

Pascal Reichmuth Rikai AG, Switzerland

«Thanks to the comprehensive strategy workshop with Decomplix, we understand how to classify and develop our product Rikai as medical device software.»

Nicolas Höfler Groupe Mutuel, Switzerland

«Decomplix gives us the necessary security in the use of software as a medical device during digitalization.»

Runa Emura Konan Medical Inc., Japan

«Decomplix quickly provides us with new and updated information on medical devices in Switzerland. We are very satisfied with their service.»

Teija Ålander Orkla – Wound Care, Sweden

«We are very satisfied with the support and helpful knowledge of Decomplix as CH-REP.»

Thomas Farner Axon Lab AG, Switzerland

«Thanks to Decomplix' great expertise, pragmatic approach and support, we were ready for the CH requirements for IVD/MD importers and CH-REPs within a short time.»

Explore other CE marking services
that match your needs

Medical device regulatory strategy and gap analyses

Get a solid starting position that saves you time in your project and supports you heading in the right direction.

Technical documentation for medical devices

Make your technical documentation compliant with tailored gap analyses, rapid feedback and compilation support.

EU MDR/IVDR & MedDO/IvDO consulting

Gain clarity with expert opinions on your compliance questions and assumptions to prevent misinterpretation.

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