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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MedtecLIVE 2024

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Posts - that's to be discovered on the topic (15)

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.

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.

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.

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.

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.

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.

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.

Best practice

MDR transfer of an AED

Gaining MDR (Medical Device Regulation) approval can be challenging. Corscience helps create an efficient pathway to MDR conformity for a Class III medical device.

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.

Market & Industry

Common Specifications addressing Annex XVI Devices

In a significant development for the Medical Device Regulation (MDR) landscape, the adoption of the Common Specifications within the Commission Implementing Regulations 2022/2346 and 2022/2347 on 1st of December 2022 marks a pivotal milestone.

MedtecLIVE 2024

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Events (1)

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

MedtecLIVE 2024

MedtecLIVE 2024 MedtecLIVE

Providers (10)

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.

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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.

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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.

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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.

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MedtecLIVE

MedtecLIVE 2024 is the leading trade fair in Europe for the development and manufacture of medical technology

Corscience GmbH & Co. KG

Defibrillation solutions. Faster. Corscience is the manufacturer-independent partner for defibrillation and monitoring. We offer engineering and consulting services as well as established and customizable solutions. In doing so, we support you in bringing your solutions to market faster.

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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.

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Hohenstein Laboratories GmbH & Co. KG

Hohenstein is your partner for testing & evaluation of medical devices

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novineon CRO GmbH

novineon CRO ist ein führendes Dienstleistungsunternehmen für Forschung und Zulassung. Seit zwei Jahrzehnten unterstützen wir Hersteller von Medizinprodukten und In-vitro-Diagnostika (IVD) bei klinischen und regulatorischen Aufgaben rund um die Konformitätsbewertung.

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