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 (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.

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.

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.

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.

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.

Eurofins - Medical Device Testing, Consulting & Sterile Packaging Hall 1 / 1-812
Service

New Requirements for the Toxicological Risk Assessment of Extractable and Leachable Components

As part of chemical characterization, our experts are ready to assist you with the toxicological assessment of extractable and leachable components following the latest requirements of ISO 10993-17:2023.

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.

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.

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