Services

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 (14)

Psilkon GmbH & Co. KG 1 / 1-405
Market & Industry

Psilkon acquires Preox.RS GmbH

Strong together - with the acquisition of Preox.RS GmbH, Psilkon GmbH & Co. KG completes its portfolio and becomes a full-service provider in the medical sector.

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.

seleon GmbH
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.

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
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).

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
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.

seleon GmbH
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.

JÜKE Systemtechnik GmbH 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.

Corscience GmbH & Co. KG 1 / 1-536
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.