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.

Regulation

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MedtecLIVE 2024
MedtecLIVE 2024 Everything

Posts - that's to be discovered on the topic (26)

MedtecLIVE
Best practice

Valuable tips on how to navigate through the regulatory jungle

At MedtecLIVE 2023 in Nuremberg, Steffen Eschinger, strategy consultant for medical technology companies, reported on which procedures have proven to be effective for the (re)certification of medical devices and which pitfalls should be avoided at all costs.
MedtecLIVE
Interview

Interview with Christian Johner: "The bottleneck of notified bodies is starting to ease."

In view of the MDR hurdles, medical technology manufacturers are considering launching their products on the US market first. But there is light at the end of the tunnel in the EU, says Christian Johner, founder and partner of the Johner Institute, in an interview with Inside Industry.
MedtecLIVE
Interview

Interview on the AI Act: "A step towards more planning security in research and development"

On 13 March 2024, the EU Parliament adopted the AI Act, which regulates the placing on the market of products with artificial intelligence. We spoke to Hans-Peter Bursig from the Electrical and Electronic Manufacturers Association (ZVEI) about what medical technology companies should consider now.
JÜKE Systemtechnik GmbH Hall 1 / 1-628
Service

Regulatory Affairs

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.
ALLTEC Angewandte Laserlicht Technologie GmbH Hall 1 / 1-408
Best practice

The laser marking solution for medical technology

The UDI guideline introduced by the FDA (Food and Drug Administration) requires medical products to be clearly labeled. This ensures traceability. Correct implementation is a concern for medical device manufacturers and raises a number of questions.
seleon GmbH Hall 1 / 1-316
Service

Consulting Services of seleon GmbH

We are not “THE CONSULTANTS”, but engineers, clinical and regulatory experts as well as quality managers whose profound expertise is based on a multitude of international development, manufacturing and approval projects of medical devices.
Hohenstein Laboratories GmbH & Co. KG Hall 1 / 1-917
Service

Biocompatibility — crucial for compatibility

The biocompatibility of medical devices is crucial to ensure that they are compatible in contact with the human body. Hohenstein offers various biocompatibility tests in accordance with the DIN EN ISO 10993 and DIN EN ISO 18562 series of standards.
MedtecLIVE
Interview

‘Conformity to standards means that everything relating to the process is documented’

According to the Federal Office for Drugs and Medical Devices, risk reports have multiplied, often due to ‘inadequate manufacturing processes’. It’s important to make sure that processes are validated to avoid errors. We spoke about this with expert Robert Schreiner from Novoplast Schlauchtechnik.
Früh Verpackungstechnik AG Hall 1 / 1-328
Service

Accredited laboratory services

We also offer our quality standards, which we apply to our own machines and processes, to our customers in the form of services: 14 test methods are accredited in accordance with ISO/IEC 17025.
NMI Naturwissenschaftliches und Medizinisches Institut Hall 1 / 1-518a
Service

MIK - MDR- & IVDR-Competence Centre

As a competence center, MIK offers consulting and development capacities and is oriented towards the needs and requirements of the industry. The holistic approach of MIK accompanies you on the way from the idea to the certification of your innovative products.
MedtecLIVE 2024
MedtecLIVE 2024 Everything

Past events (3)

Exhibitor Presentation

Jun 20, 2024 10:30 AM - 11:00 AM | Exhibitor Forum (1-916)

The Importance of Transparency in Regulatory Documentation
Impulse talks & discussion

Jun 19, 2024 3:00 PM - 4:30 PM | Forum (1-331)

"Speed up time to market" - digitalisation and AI for a faster and safer regulatory process
Exhibitor Presentation

Jun 19, 2024 1:30 PM - 2:00 PM | Exhibitor Forum (1-916)

Everyone is talking about digitalization - we are doing it, learnings and best practices from customer projects
MedtecLIVE 2024
MedtecLIVE 2024 Everything

Providers (17)

seleon GmbH

seleon GmbH has been a leading service partner for medical technology companies in Central Europe for 26 years, focusing on the areas of development, consulting and production.

Hall 1 / 1-316

JÜKE Systemtechnik GmbH

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.

Hall 1 / 1-628

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 1 / 1-328

Eurofins - Medical Device Testing, Consulting & Sterile Packaging

Eurofins is a world leader in the testing, cleaning, packaging and sterilization of medical devices. The consulting team has expertise in a wide range of products and manufacturing processes to assess the biological risks of a new product design or process change.

Hall 1 / 1-812

ALLTEC Angewandte Laserlicht Technologie GmbH

FOBA Laser Marking + Engraving (brand of ALLTEC Angewandte Laserlicht Technologie GmbH) develops and supplies advanced laser technology for industrial direct part marking and engraving.

Hall 1 / 1-408

MedicalMountains GmbH

MedicalMountains GmbH is a network that connects and supports players in the medical technology sector. We promote the exchange between companies, research and politics and create platforms for dialogue. We support all players in the medical technology sector.

Hall 1 / 1-316

Corscience GmbH & Co. KG

Defibrillationslösungen. Schneller. Corscience ist der herstellerunabhängige Partner für Defibrillation und Monitoring. Wir bieten Engineering- und Beratungsleistungen sowie etablierte und anpassbare Lösungen. Damit unterstützen wir Sie dabei, Ihre Lösungen schneller auf den Markt zu bringen.

Hall 1 / 1-536

MedtecLIVE

MedtecLIVE 2024 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 1 / 1-518a