Your Compliance Partner

Our team of proven experts guides you
on market access.

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 a shared vision of enabling innovation and promoting the availability of useful medical devices.

Our proven experts guide you with hands-on support

decomplix

Markus Angst

Senior Regulatory & Quality Consultant

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.

decomplix

Beni Hirt

Customer Relations & CEO

Beni 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.

decomplix

Helena Lacalle

Regulatory Affairs Director

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.

decomplix

Josef Neubauer

Quality & Account Manager Austria

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 useability of the processes he designs.

decomplix

Oliver Lammer

RA/Q Specialist

Oliver Lammer is a Biomedical Engineer with a Master’s degree from the University of Bern. A trained developer in electronic implants, he has a broad understanding of the technical aspects of the R&D of medical devices. He collaborated on several innovative medical projects with the University of Applied Sciences Biel/Bienne and currently supports Innosuisse projects in the development of AI-based medical applications.

decomplix

Hansjörg Riedwyl

Board member

Hansjörg Riedwyl is a key enabler and idea generator of Decomplix. He brings his network and knowledge from over 20 years in Medtech and as former CEO of ISS AG, Integrated Scientific Services to the Board of Directors and helps to shape the strategic positioning.

decomplix

Rudolf Blankart

Professor of Regulatory Affairs, University of Bern

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

Markus Angst

Senior Regulatory & Quality Consultant

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.

decomplix

Beni Hirt

Customer Relations & CEO

Beni 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.

decomplix

Helena Lacalle

Regulatory Affairs Director

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.

decomplix

Josef Neubauer

Quality & Account Manager Austria

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 useability of the processes he designs.

decomplix

Oliver Lammer

RA/Q Specialist

Oliver Lammer is a Biomedical Engineer with a Master’s degree from the University of Bern. A trained developer in electronic implants, he has a broad understanding of the technical aspects of the R&D of medical devices. He collaborated on several innovative medical projects with the University of Applied Sciences Biel/Bienne and currently supports Innosuisse projects in the development of AI-based medical applications.

decomplix

Hansjörg Riedwyl

Board member

Hansjörg Riedwyl is a key enabler and idea generator of Decomplix. He brings his network and knowledge from over 20 years in Medtech and as former CEO of ISS AG, Integrated Scientific Services to the Board of Directors and helps to shape the strategic positioning.

decomplix

Rudolf Blankart

Professor of Regulatory Affairs, University of Bern

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.

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.

All you need from one source

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.

CEplus GmbH is a Germany-based regulatory affairs provider for medical and in-vitro diagnostic devices. CEplus' knowledge and people help to speed 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 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.

Latest from our blog

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 Certificate

Want to work for Decomplix?

Looking 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 postings