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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 (92)

Rocketing Healthcare Podcast Hall 1 / 1-646c
Interview

Rocketing Healthcare Podcast: Special episode START HEALTHCARE x MedtecLIVE 2024

In the run-up to MedTec Live, we have published a special episode highlighting the importance of MedTec Live for start-ups and the medical technology industry

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.

seleon GmbH Hall 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).

seleon GmbH Hall 1 / 1-316
Service

Medical technology in perfection

The production area – as one of three business divisions of seleon GmbH – has been dealing with the assembly and testing of mainly electro-mechanical assemblies and devices in the segment of active medical technology for more than 20 years.

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".

JÜKE Systemtechnik GmbH Hall 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.

JÜKE Systemtechnik GmbH Hall 1 / 1-628
Interview

Outsourcing as a success strategy in medical technology

The manufacture of technical products, devices, and systems, and often the development, is increasingly being outsourced to strategic partners, which have specific technological and production expertise and the required infrastructure.

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.

SurFunction GmbH Hall 1 / 1-540k
Service

New generation of laser-based surface functionalization for improved biocompatibility

SurFunction is presenting the innovative ELIPSYS® technology at MedtecLIVE 2024: Extended Laser Interference Patterning System is the newly developed revolutionary generation of laser interference treatment of implant surfaces and instruments and is a possible alternative to PFAS.

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