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 (10)

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.

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.

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!

Digital Life Sciences GmbH

All-in-one Software for Success in Quality Management

The eQMS suite from Digital Life Sciences GmbH is based on an integrated ECM and DMS system that meets the highest standards of quality and compliance. All software solutions can be expanded in a modular fashion to form a complete GxP-compliant eQMS suite.

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.

Früh Verpackungstechnik AG

Sterilization as the interface between product, process and evidence

For many medical devices and packaging systems, sterilization is a critical interface between product design, process definition and regulatory evidence. This is where microbiological data, validation strategy and documentation requirements must be considered together.

M&M Software GmbH

Market & Industry

DiGA Regulation 2.0: Why 2026 is a turning point for digital health applications (DiGA)

The Second Ordinance amending DiGAV, effective Feb 1, 2026, fundamentally updates the DiGA regulatory framework. Moving from selective evidence to continuous, real-world data evaluation, it brings manufacturers more transparency, higher data obligations, and new opportunities.

M&M Software GmbH

FDA Relaxes Rules for Wearables & Wellness Apps: What Does This Mean for Digital Health and MedTech?

The FDA provides new clarity: wearables and wellness apps are to be less strictly regulated. For manufacturers, start-ups and tech players, this means more leeway, but also new risks.

QT9 Software Ltd

Automate Quality and Compliance with QT9 QMS

See why more than 1,200 users trust QT9's full-suite QMS software to automate audits, streamline operations and scale safely. Get accessible control and regulatory excellence.

M&M Software GmbH

Update of Product Lifecycle Processes: Compliance Meets Modern Toolchain

The product and software lifecycle processes were adapted to changed regulatory requirements and combined with a modern toolchain. The result: lean processes, digital efficiency, and full compliance.

Events (3)

MedtecLIVE 2026 Everything

Exhibitor Presentation

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

Wonderful World of Biocompatibility. Recent Updates and Challenges

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?

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

Adequate information security for medical devices

Providers (9)

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

M&M Software GmbH

M&M Software has been a global software and digitization partner for almost 40 years. 360 employees in Germany, China, and India develop customized digital solutions with measurable value. Since 2025, SEQLY has complemented the portfolio as a consulting brand, combining strategy and technology.

Hall 3 / 3-216

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

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

PeakAvenue GmbH

PeakAvenue develops software for engineering, quality, and risk management in the medical technology sector. Our eQMS platform supports companies with MDR-, ISO 13485-, and ISO 14971-compliant processes, end-to-end traceability, and efficient product development.

Hall 3 / 3-216

Digital Life Sciences GmbH

Digital Life Sciences GmbH offers innovative and practical solutions in the field of digital document and quality management. We provide targeted support for your digital transformation, including consideration of your regulatory requirements.

Hall 3 / 3-438

QT9 Software Ltd

QT9 QMS is a fully integrated electronic quality management system (QMS) that unifies processes, documentation and compliance in one platform. With 25+ modules, real-time metrics and pre-validated workflows, it helps organizations streamline operations, ensure compliance and scale securely.

Hall 3 / 3-135