Our proven experts guide you
on medical device market access.
Each customer is unique, so Decomplix adjusts the service and pricing to their real needs. Whether it’s a certification experience from one source or simply guidance on the regulatory pathway, we are constantly challenging the definition of what it means to be a compliance partner – with a shared vision of enabling innovation and promoting the availability of useful medical devices.
Markus Angst has more than 25 years of experience in medical devices, including sterile and implantable devices, biomechanics, quality engineering, quality management, and regulatory affairs. Markus Angst holds an MSc from ETH Zurich in mechanical engineering.
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.
Heike Idink is a Regulatory Affairs & Quality Management professional with more than 20 years of experience in regulated fields like Medical Devices, Biotechnology and pharmaceuticals. Heike Idink holds a PhD of Natural Sciences from the RWTH Aachen, Germany, and a Master of Business Law from FFHS, Switzerland. With her extensive regulatory expertise, she supports Decomplix clients in particular with questions relating to in-vitro diagnostics and due diligence assessments.
Helena Lacalle is a Regulatory Affairs professional with over 20 years of experience in strictly regulated fields like medical devices and pharmaceuticals. Helena Lacalle holds a pharmacist degree from the University of Barcelona, a Master degree in Statistics from the University of Neuchatel, Switzerland, and has strong language skills in English, French, and Spanish. With her extensive regulatory expertise, she supports Decomplix’ customers both on strategic levels and on detailed regulatory questions.
Josef Neubauer is a Biomedical Engineer with a Master’s degree from the University of Applied Sciences Technikum Wien and 10+ years of professional experience in the field of quality management for medical devices. He gained his experience with start-ups and SMEs in Austria. A former software developer, he also has a natural affinity for software in the QM field and has a particular eye for the usability of the processes he designs.
Oliver Lammer is a Biomedical Engineer with a Master’s degree from the University of Bern, complemented by a Master of Advanced Studies (MAS) in Regulatory Affairs. Specialized in prototype development of electronic implants, he has a comprehensive understanding of the technical aspects of medical devices. Oliver is actively supporting the development of AI-based medical applications in an Innosuisse project, following his engaged contributions to innovation projects at the University of Applied Sciences Biel/Bienne.
Danyan Zimmermann-Lai has a legal background and a Master’s degree from the University of Milan. With her experience in the legal and importer businesses and her passion for regulatory matters, she has been maintaining control of Decomplix’ CH-REP activities from the beginning.
As Professor of Regulatory Affairs at the KPM Center for Public Management at the University of Bern and the Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel), Rudolf Blankart supports the Decomplix Board of Directors at the interface of medicine, management and law. With his strong background in science and practice, he is active as a policy expert both nationally and internationally.
Markus Angst has more than 25 years of experience in medical devices, including sterile and implantable devices, biomechanics, quality engineering, quality management, and regulatory affairs. Markus Angst holds an MSc from ETH Zurich in mechanical engineering.
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.
Heike Idink is a Regulatory Affairs & Quality Management professional with more than 20 years of experience in regulated fields like Medical Devices, Biotechnology and pharmaceuticals. Heike Idink holds a PhD of Natural Sciences from the RWTH Aachen, Germany, and a Master of Business Law from FFHS, Switzerland. With her extensive regulatory expertise, she supports Decomplix clients in particular with questions relating to in-vitro diagnostics and due diligence assessments.
Helena Lacalle is a Regulatory Affairs professional with over 20 years of experience in strictly regulated fields like medical devices and pharmaceuticals. Helena Lacalle holds a pharmacist degree from the University of Barcelona, a Master degree in Statistics from the University of Neuchatel, Switzerland, and has strong language skills in English, French, and Spanish. With her extensive regulatory expertise, she supports Decomplix’ customers both on strategic levels and on detailed regulatory questions.
Josef Neubauer is a Biomedical Engineer with a Master’s degree from the University of Applied Sciences Technikum Wien and 10+ years of professional experience in the field of quality management for medical devices. He gained his experience with start-ups and SMEs in Austria. A former software developer, he also has a natural affinity for software in the QM field and has a particular eye for the usability of the processes he designs.
Oliver Lammer is a Biomedical Engineer with a Master’s degree from the University of Bern, complemented by a Master of Advanced Studies (MAS) in Regulatory Affairs. Specialized in prototype development of electronic implants, he has a comprehensive understanding of the technical aspects of medical devices. Oliver is actively supporting the development of AI-based medical applications in an Innosuisse project, following his engaged contributions to innovation projects at the University of Applied Sciences Biel/Bienne.
Danyan Zimmermann-Lai has a legal background and a Master’s degree from the University of Milan. With her experience in the legal and importer businesses and her passion for regulatory matters, she has been maintaining control of Decomplix’ CH-REP activities from the beginning.
As Professor of Regulatory Affairs at the KPM Center for Public Management at the University of Bern and the Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel), Rudolf Blankart supports the Decomplix Board of Directors at the interface of medicine, management and law. With his strong background in science and practice, he is active as a policy expert both nationally and internationally.
Decomplix is based on the profound expertise of our best-in-class partners. Through this responsible network, we can also provide additional services and pricing approaches.
Evidencio enables very fast and cost-efficient market access for clinical algorithms as a legal manufacturer. Through the Evidencio platform, software algorithms from Decomplix customers can be transformed into CE-certified medical device software (MDSW) in an easy and scalable manner.
sitem-insel AG aims to facilitate the application of research results in medicine (translation). It provides researchers with training, consulting and infrastructure and offers Decomplix access to important clinical areas.
As a cloud pioneer, netrics AG provides secure IT services from its own Swiss-based data centers in combination with cloud offers, particularly for highly regulated markets like health care and the medical device industry.
Beutler Künzi Stutz AG is our specialist for legal affairs. Our customers benefit from their knowledge and experience in international data protection compliance, intellectual property and information technology matters.
Creaholic is an innovation factory focused on inventing and innovation culture. Having these makers, doers, and prototypers aboard help circumvent the pitfalls of launching a new product or business.
As a service provider for regulatory affairs and quality management Congenius extends our workbench for QMS setups for our customers and contributes specific regulatory and clinical knowledge.
Integrated Scientific Services, ISS AG' staff ensures capacities, considerable knowledge and experience in the areas of medical device software development, quality management, clinical and regulatory affairs.
«Decomplix gives us the necessary security in the use of software as a medical device during digitalization.»
«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.»
«Due to service quality, regulatory knowledge, and reliability, we can highly recommend Decomplix as CH-REP.»
«We benefited tremendously from Decomplix's experience and expertise in working with the Swiss authority, Swissmedic, and with Notified Bodies.»
«With Decomplix as our CH-REP and partner, we feel well-supported. The collaboration is exceptionally professional and efficient.»
«It feels very good to have Decomplix as CH-REP.»
«We are very satisfied with the support and helpful knowledge of Decomplix as CH-REP.»
«Decomplix offers a professional approach and streamlined process for compliance and specific requirements of the Swiss market.»
«We appreciate the clear procedure, the professional approach, and the uncomplicated cooperation and highly recommend Decomplix as a business partner.»
«With the regulatory evaluation of our planning software, we were able to take key steps in product development with Decomplix.»
«As a premium manufacturer of ophthalmic instruments, we feel very secure 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.»
«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»
«For our digital health initiatives, we feel we are in safe hands with Decomplix.»
«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 quickly provides us with new and updated information on medical devices in Switzerland. We are very satisfied with their service.»
«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»
«Thanks to the comprehensive strategy workshop with Decomplix, we understand how to classify and develop our product Rikai as medical device software.»
«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.»
Our ISO 13485
Services as Swiss Authorised Representative and in the areas of design and development, documentation, quality management and regulatory affairs for medical devices.
See CertificateLooking for a new challenge? Are you inspired by the idea of accelerating innovation in the medical industry? Do you thrive on diversity?
See our job postingsYou will receive regular updates around regulation of medical devices.
