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 (20)

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.

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Service

Consulting for Medical Devices

Ready for the MDR? We support you with documentation and assessment for your medical devices, covering biocompatibility, sterilization, reprocessing, packaging, and shelf life.

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Product

BAYOOSOFT Themis: Technical documentation reimagined

Efficient and compliant with standards: Your validated solution for documentation processes of medical devices and in vitro diagnostics – Digitize linked processes and sustainably reduce documentation efforts while minimizing redundant data.

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Service

LNE-GMED UK, newly designated as an Approved Body under UK Medical Device Regulations

Previously designated as an Approved Body for non-medical regulations since October 2022, LNE-GMED UK, a GMED subsidiary of the LNE Group, has expanded its services to medical devices since January 2024 and can now offer certification services in this field.

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Service

Accompanying you in the transition to the European Medical Device Regulation

GMED, and its subsidiaries GMED North America and LNE-GMED UK, provide comprehensive solutions to support you throughout the certification of your medical devices (MDs) and in vitro diagnostic medical devices (IVDs).

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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.

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Service

Welcome to novineon - your partner for Clinical & Regulatory Affairs

Your medical device and our experience from over 20 years. We shape your path to CE conformity and beyond — from clinical investigation/evaluation to PMCF.

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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.

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Service

Accredited test laboratory for medical devices

CleanControlling Medical GmbH & Co. KG is the accredited testing laboratory in the "world center of medical technology" and offers a comprehensive portfolio of biological, microbiological-hygienic and chemical tests.

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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.

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Providers (13)

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.

Fehraltorf, Switzerland

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.

Altenberge, Germany

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.

Selmsdorf, Germany

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.

Heilbronn, Germany

MedtecLIVE

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

Nürnberg, Germany

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.

Erlangen, Germany

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.

Tuttlingen, Germany

Eurofins - Medical Device Testing, Consulting & Sterile Packaging

Eurofins ist weltweit führend bei der Prüfung, Reinigung, Verpackung und Sterilisation von Medizinprodukten. Das Consultingteam verfügt über Fachwissen zu einer Vielzahl von Produkten und Herstellungsprozessen, um die biologischen Risiken eines neuen Produktdesigns oder Prozessänderung zu bewerten.

Planegg / München, Germany

CleanControlling Medical GmbH & Co. KG

CleanControlling Medical GmbH & Co. KG is your partner as an accredited and ZLG and GLP accepted testing laboratory for biological and microbiological-hygienic testing of medical devices.

Emmingen-Liptingen, Germany