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They must comply with all medical regulations in full before the product can even go to market. These are accompanied by several norms, standards and processes like the European Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Devices Regulation (IVDR). In order to succeed, medical technology manufacturers rely heavily on the training and expertise of their staff.

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Posts - that's to be discovered on the topic (58)

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
Market & Industry

Driving innovation and growth: Enterprise Ireland and the MedTech industry

Ireland is one of the largest medtech hubs in the world - thanks in part to Enterprise Ireland, the government agency that promotes the growth and development of local companies. In 2023, MedtecLIVE was a platform for establishing contacts with the "Emerald Isle".

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

Eurofins - Medical Device Testing, Consulting & Sterile Packaging 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.

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.

seleon GmbH 1 / 1-316
Market & Industry

The AI Act is (almost) here!

In April 2021, the European Commission published a proposal for a “Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union acts” (Proposal EU AI Act).

MedtecLIVE
Interview

"100 per cent medical technology"

Key Account Manager Silke Ludwig and Sales Manager Jessica Nether make up the MedtecLIVE sales team and are two of its most recognisable faces. We wanted to know from them what exhibitors and visitors can expect at the next edition in Stuttgart from 18 to 20 June 2024.

seleon GmbH 1 / 1-316
Service

Project Examples: nothing is more convincing than reality

In partnership with national and international customers, seleon develops individual solutions for complex medical technology devices. Through extensive engineering knowledge and years of experience, we consistently and efficiently transform your ideas into medical technology products and lead them.

JÜKE Systemtechnik GmbH 1 / 1-628
Service

Flexible manufacturing and production focused on the needs and requirements of customers

Contract Manufacturing: We specialize in the manufacture of devices and assemblies in large and smaller quantities, can build prototypes and test setups, and are familiar with handling different variants.

seleon GmbH 1 / 1-316
Novelty

seleon-CRO Starter Kit

Discover our comprehensive CRO Starter Kit and inform yourself in our compilation about all relevant laws, guidelines and standards in the area of Clinical Affairs. Use our detailed checklists to get a comprehensive impression of the regulatory requirements and assess your status at the same time.

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