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Compliant solutions for regulatory
challenges with medical software.
Symptom checkers and patient triage software are increasingly part of the services offered by Health Insurers. This type of software qualifies as Medical Device Software (MDSW) in Switzerland and in the EU. Health Insurers who make available such software to their customers become medical device importers, distributors, or even manufacturers. These roles entail significant regulatory duties.
Without relevant regulatory expertise, Health Insurers may not be aware of the compliance implications until they receive a notification from the competent authority asking about the CE marking status of the software. To prevent this unpleasant scenario, Decomplix drives you through the requirements and options that ensure compliance.
Decomplix’ Health Insurer MDSW services include:
We identify for you whether or not the software qualifies as MDSW under EU MDR and IVDR, and determine the economic operator role you endorse.
Where MDSW qualification is certain, we ensure its smooth regulatory integration, with options for minimizing the related duties under Swiss and EU legislation.
For legal manufacturer role: we offer an option for outsourcing to a third-party legal manufacturer.
For Swiss importer role: we can undertake the regulatory tasks on behalf of the Health Insurer.
We draft, review, and negotiate the necessary quality assurance agreements (QAA) to be established with the MDSW manufacturers.
We set up relevant processes that can be embedded into those already existing at the Health Insurer.
At all times, we offer continuous and tailored regulatory support and training to the Health Insurer’s relevant staff.
Decomplix places its extensive experience in this area at the service of Swiss Health Insurers. We help you determine whether the software you make available qualifies as MDSW, and, if so, provide you with the necessary regulatory and quality support to understand and correctly deploy your role in the medical device supply chain.
Our support can be structured in a modular manner to suit your needs at your own pace. If you, as a Swiss health insurer, take on the role of a Swiss importer of MDSW, you can outsource parts of the regulatory processes to Decomplix. This helps simplify your team’s tasks and required competencies while minimizing liability and regulatory risks.
The requirements for a medical device software manufacturer impact quality management system (QMS) processes, qualified personnel, software lifecycle management, Notified Body’s certification, and post-market obligations. Manufacturers and CE-marked devices must be registered in the appropriate national or supranational databases.
An importer who modifies a third-party MDSW on its own account becomes a manufacturer.
As importers of MDSW, health insurers are responsible, for placing only compliant products on the market and ensuring traceability. Swiss importers are also registered with Swissmedic. They are subject to inspection by the competent authority and must co-operate in the post-market phase.
Health insurers acting as importers must be aware that certain actions turn an importer into a legal manufacturer of MDSW with additional obligations. Such an act can be, for example, the modification of an MDSW from a third-party supplier for one’s own account or the provision of an MDSW on the market under one’s own name without an agreement with the manufacturer.
With the right advice, importers of MDSW avoid unexpectedly assuming manufacturer obligations.
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
Email
+41 79 668 02 60
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.
«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.»
«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.»
«Due to service quality, regulatory knowledge, and reliability, we can highly recommend Decomplix as CH-REP.»
«Decomplix gives us the necessary security in the use of software as a medical device during digitalization.»
«It feels very good to have Decomplix as CH-REP.»
«Thanks to the comprehensive strategy workshop with Decomplix, we understand how to classify and develop our product Rikai as medical device software.»
«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.»
«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»
«Decomplix quickly provides us with new and updated information on medical devices in Switzerland. We are very satisfied with their service.»
«We are very satisfied with the support and helpful knowledge of Decomplix as CH-REP.»
«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.»
«We benefited tremendously from Decomplix's experience and expertise in working with the Swiss authority, Swissmedic, and with Notified Bodies.»
«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»
«With the regulatory evaluation of our planning software, we were able to take key steps in product development with Decomplix.»
«Decomplix offers a professional approach and streamlined process for compliance and specific requirements of the Swiss market.»
«As a premium manufacturer of ophthalmic instruments, we feel very secure with Decomplix.»
«We appreciate the clear procedure, the professional approach, and the uncomplicated cooperation and highly recommend Decomplix as a business partner.»
«With Decomplix as our CH-REP and partner, we feel well-supported. The collaboration is exceptionally professional and efficient.»
«For our digital health initiatives, we feel we are in safe hands with Decomplix.»
We support you in implementing the new regulatory requirements on time and in a structured way.
Overcome regulatory hurdles more efficiently and securely with us.
Transform your algorithm into a CE-certified medical device software in less than a year.
Get a solid starting position that saves you time in your project and supports you heading in the right direction.
Make your technical documentation compliant with tailored gap analyses, rapid feedback and compilation support.
You will receive regular updates around regulation of medical devices.
