In contrast to a consultant, we can assume the pre- and post-market responsibility as the legal manufacturer. We provide compliance staff, a Notified Body and ISO 13485 certification to the partnership. To stay on the market, we maintain the CE certificate and stand by your side.
Discover our services
We simplify market access for medical devices.
It can be complicated, expensive and time-consuming to certify medical devices on your own. Our solution solves this problem by providing you with compliance staff so that your company and product meet the increasing regulatory demands fast and hassle-free.
Our goal is to simplify and speed up the CE certification of your medical product.
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 the shared vision of accelerating innovation and encouraging the breakthrough of great ideas.
We go beyond consulting as a legal manufacturer
Our proven experts guide you through the CE certification
Markus Angst Senior Regulatory & Quality ConsultantDecomplix AG
Beni Hirt Customer Relations & CEODecomplix AG
Markus Angst
Senior Regulatory & Quality ConsultantDecomplix AGMarkus 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
Customer Relations & CEODecomplix AGBeni Hirt has over 10 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.
Helena Lacalle Senior Regulatory Affairs ManagerDecomplix AG
Robert Matovinovic Senior Quality ManagerDecomplix AG
Helena Lacalle
Senior Regulatory Affairs ManagerDecomplix AGHelena 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.
Robert Matovinovic
Senior Quality ManagerDecomplix AGRobert Matovinovic has over 20 years of experience in quality management, project management and product development in the Medtech industry, mainly for small companies. The mechanical engineer from the Technical University of Munich, builds, maintains and certifies customer-specific quality management systems according to ISO 13485 and supports Decomplix’ customers in CE-certification of medical devices of various classes, including the preparation of technical documentation according to MDD and MDR.
Josef Neubauer Quality & Account Manager AustriaDecomplix AG
Sandra Item Head of Regulatory Affairs & Knowledge ManagementISS AG, Integrated Scientific Services
Hansjörg Riedwyl Business & Regulatory Strategies, CEOISS AG, Integrated Scientific Services
Matthias Steck Senior Software EngineerISS AG, Integrated Scientific Services
Michel Weber PhD Head of Clinical ServicesISS AG, Integrated Scientific Services
Rudolf Blankart Professor of Regulatory Affairs, University of Bern
Markus Angst Senior Regulatory & Quality ConsultantDecomplix AG
Markus Angst
Senior Regulatory & Quality ConsultantDecomplix AGMarkus 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 Customer Relations & CEODecomplix AG
Beni Hirt
Customer Relations & CEODecomplix AGBeni Hirt has over 10 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.
Helena Lacalle Senior Regulatory Affairs ManagerDecomplix AG
Helena Lacalle
Senior Regulatory Affairs ManagerDecomplix AGHelena 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.
Robert Matovinovic Senior Quality ManagerDecomplix AG
Robert Matovinovic
Senior Quality ManagerDecomplix AGRobert Matovinovic has over 20 years of experience in quality management, project management and product development in the Medtech industry, mainly for small companies. The mechanical engineer from the Technical University of Munich, builds, maintains and certifies customer-specific quality management systems according to ISO 13485 and supports Decomplix’ customers in CE-certification of medical devices of various classes, including the preparation of technical documentation according to MDD and MDR.
Josef Neubauer Quality & Account Manager AustriaDecomplix AG
Sandra Item Head of Regulatory Affairs & Knowledge ManagementISS AG, Integrated Scientific Services
Hansjörg Riedwyl Business & Regulatory Strategies, CEOISS AG, Integrated Scientific Services
Matthias Steck Senior Software EngineerISS AG, Integrated Scientific Services
Michel Weber PhD Head of Clinical ServicesISS AG, Integrated Scientific Services
Rudolf Blankart Professor of Regulatory Affairs, University of Bern
We can provide all you need for your compliance from one source.
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.
ISS AG, Integrated Scientific Services’ staff ensures capacities, considerable knowledge and experience in the areas of medical device software development, quality management, clinical and regulatory affairs.
CE plus GmbH is a Germany-based regulatory affairs service provider for medical devices and in-vitro diagnostics. CEplus supports with regulatory expertise in development and speeds up the market access for our customers.
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 data protection, 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.
Optimo Medical AG is a related start-up providing software as a medical device for surgeons. We collaborate with Optimo to share know-how and gain better understanding of start-up needs.
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Certification of a Quality Management System according to ISO 13485
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See CertificateWant to work for Decomplix?
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