Regulation

Whether it's the European Medical Device Directive (MDD) or other international regulations. It is important for the medical device industry to keep abreast of the latest regulatory developments.

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Posts - that's to be discovered on the topic (18)

MedtecLIVE 2026 Everything

Eurofins Medical Device Services

What’s New in the World of ISO 10993‑1?

With the newly revised and completely restructured ISO 10993‑1, regulatory expectations are becoming significantly stricter. In our video, Marcel Dörkes explains the key changes introduced in the updated ISO 10993‑1.

Ingenics AG

Balancing Innovation and Regulation in the Medical Device Industry Cost-Effectively

In medical technology, balancing innovation with strict regulation is critical. Learn how to reduce costs through optimized processes and strategic consulting while ensuring full compliance for your medical devices.

Metecon GmbH

Regulatory Resilience: Why MedTech Companies Need a New Approach

Many organisations meet regulatory requirements yet operate on systems that react poorly to change. This article explains why resilience is becoming a core capability for MedTech – and how companies can build it step by step.

OEB SRL

Hall 3 / 3-344f

High Standards, ISO 13485 Certified Processes, and Sure Results

We have CNC and DMLS systems dedicated to this sector. All processes are ISO 13485 certified, from raw materials to the finished product. Our entire supply chain is validated for the medical industry, and we produce monolithic or assembled parts for leading medical prosthetics companies.

Lorit Consultancy

Master Medical Device Compliance: IEC 60601, IEC 62304 & Cybersecurity

Struggling with safety standards, software processes or cybersecurity requirements? Get clear, practical guidance to finally move your product towards approval.

NewTec GmbH

Secure Development of Medical Technology: Safety, Security & MDR Compliance

Learn how to master the challenges of the MDR and efficiently develop safety-critical medical technology. From safety and security to usability engineering.

Solectrix GmbH

Your partner throughout the entire development cycle

We support you at every stage and ensure that regulatory, standard-related and quality aspects are an integral part of your project right from the start.

NMI Naturwissenschaftliches und Medizinisches Institut

Hall 3 / 3-430a

MIK - MDR & IVDR competence center

Consulting, development support, and testing of medical devices: we support you every step of the way, from the initial idea to the certification of your innovative products!

BAYOOSOFT GmbH

Market & Industry

Medical technology regulation reimagined: Structure instead of complexity with DIN SPEC 91509

How a standardized data model is reshaping medical technology regulation and enabling more efficient, transparent, and scalable compliance processes today.

PeakAvenue GmbH

Digital Quality and Compliance in Medical Technology

MDR, ISO 13485, and ISO 14971 place high demands on medical technology companies. Digital and connected processes create transparency, enable end-to-end traceability, and support quality and risk management across the entire product lifecycle.

Past events (4)

MedtecLIVE 2026 Everything

May 6, 2026 3:30 PM - 4:30 PM | Forum (3-520)

Adequate information security for medical devices

Exhibitor Event

May 6, 2026 2:00 PM - 3:00 PM

Win a Free Ticket for the Usability & Human Factors MeetUp

Panel discussion

May 5, 2026 3:30 PM - 4:45 PM | Forum (3-520)

The Future of SMEs in Germany’s Medical Technology Sector: Hope Through MDR Reform?

Exhibitor Presentation

May 5, 2026 12:30 PM - 12:50 PM | Exhibitor Forum (3-347)

Wonderful World of Biocompatibility. Recent Updates and Challenges

Providers (17)

MedtecLIVE 2026 Everything

Früh Verpackungstechnik AG

We offer comprehensive services from a single source - in the highest quality, for the best possible protection of products, people and customers. From the development of customized solutions to the production of packaging materials and contract packaging to qualification and documentation.

Hall 3 / 3-518

MedtecLIVE

MedtecLIVE is the leading trade fair in Europe for the development and manufacture of medical technology

NMI Naturwissenschaftliches und Medizinisches Institut

With pioneering innovations at the interface of medicine, natural sciences and engineering. Our mission is the transfer of knowledge and technology into practice. Our guideline: NMI achieving results!

Hall 3 / 3-430a

GBA Group MedTech Solutions

GBA Group MedTech Solutions supports medical device manufacturers throughout the entire device lifecycle – from concept to market approval and post-market surveillance. We combine regulatory expertise, consulting and testing services to turn complexity into clarity.

Hall 3 / 3-313

Eurofins Medical Device Services

We are your partner for the entire life cycle of medical devices – from development to post-market surveillance. We offer a comprehensive range of services with three independent services: consulting (including RA/QA), laboratory testing and sterile packaging for medical devices.

Hall 3 / 3-212

USE-Ing. GmbH

We help manufacturers make complex medical technology intuitive and compliant. As experts in Human Factors Engineering and usability, we support you from early analysis to validated usability documentation. Visit us to see how we streamline your HF/UE processes and strengthen product safety.

Hall 3 / 3-450d

OEB SRL

High standards, certified processes, reliable results. Rigorous processes that include targeted isolation and advanced washing cycles. We are ISO 13485 certified for both instruments and prosthetics

Hall 3 / 3-344f

Metecon GmbH

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!

Hall 3 / 3-216

Ingenics AG

Ingenics Consulting is a global management consultancy specializing in performance management and planning for production and supply chains. We develop customized, sustainable solutions from operations strategy to shop floor implementation.

Hall 3 / 3-216