Benefit from the extensive and long-standing experience of our experts: We accompany the entire process, from consulting to approval requirements, standard-compliant development and production through to the certification of medical devices.
Have you defined the intended use of your medical device correctly? Is the device clarification unclear? Is your regulatory strategy adequate? Have you started compiling your technical file? Confused by too many questions?! We are here to give you the answers. Book a free consultation slot now!
Your medical device and our experience from over 20 years. We shape your path to CE conformity and beyond — from clinical investigation/evaluation to PMCF.
From development to product launch, we guide you through the complex world of regulatory affairs. Find out how our comprehensive quality and risk management and our expertise in standard-compliant documentation ensure your success. Find out more!
The approval of medical devices and in-vitro diagnostics is subject to special regulations. The heterogeneous international procedures and regulatory requirements are constantly changing and becoming ever more extensive. We keep you up to date on an ongoing basis.
Our business areas - expertise for the success of your medical devices In a constantly changing and highly regulated industry, our team of experts offers customized solutions to bring your medical devices to market safely and efficiently. Our services include:
Our customers from the medical technology, analytics, biotechnology, laboratory technology and photonics sectors appreciate our cross-industry experience and benefit from our many years of expertise in handling complex mechatronic solutions.
With new ESG regulations on the horizon and increasingly demanding customer requirements, organizations must adapt their compliance frameworks to stay competitive. Discover how compliance management offers strategic advantages beyond regulations.
Do you trust everything you hear about medical devices with AI? Like: “It is not possible to get a medical device with AI features certified in Europe”. Do you have an innovative medical device with AI in the pipeline? Trust us to demystify the AI challenges in the medical device industry.
Ready for the MDR? We support you with documentation and assessment for your medical devices, covering biocompatibility, sterilization, reprocessing, packaging, and shelf life.
novineon CRO is a leading service provider for research and regulatory affairs. For two decades we have been supporting manufacturers of medical devices and in-vitro diagnostics (IVD) in clinical and regulatory affairs related to conformity issues, e.g. clinical evaluation and clinical trials.
Tübingen, Germany
JÜKE is an experienced service provider for product development, contract manufacturing and regulatory affairs for companies in the fields of medical technology, analytics, biotechnology, laboratory technology and photonics.
Altenberge, Germany
As experts in functional safety and quality management, we are your partner for customised and practice-oriented solutions in the field of medical technology. We support you in case of bottlenecks in the areas of quality management, regulatory affairs or system engineering.
Munich, Germany
Metecon GmbH - your regulatory compliance partner. For more than 25 years we have been supporting manufacturers of medical devices and IVDs with reliable solutions in QMS, Clinical Affairs, Regulatory Affairs and PMS. Tackle regulatory challenges efficiently with Metecon - let's get in touch!
Mannheim, Germany
Matrix Requirements GmbH betreibt eine weltweit führende Software-Plattform für innovative Unternehmen der Medizintechnik, die dabei hilft, Produkte schneller zu entwickeln, und sie sicherer zu gestalten.
Kehl, Germany
senetics – your full service provider for medical devices, medical technology, laboratory equipment and companion diagnostics!
Ansbach, Germany
your partner for reliable regulatory results.
Reichenschwand, Germany
For over 30 years, BYTEC Medizintechnik has been a service provider for the development and production of medical devices for surgery, therapy and diagnostics.
Eschweiler, Germany
AI-assisted Post-Market-Surveillance automation
Vienna, Austria
Secure your exhibition space for MedtecLIVE 2026, the premier medical technology trade fair in Europe. Book now to showcase your innovations and connect with industry leaders.
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