seleon GmbH

March 28, 2024

Regulatory Blog of seleon GmbH

The approval of medical devices and in-vitro diagnostics is subject to special regulations. The heterogeneous international procedures and regulatory requirements are constantly changing and becoming ever more extensive. We keep you up to date on an ongoing basis.

February 26, 2024

Novelty

Welcome to the seleon TECH-BLOG

The place where technology come to life... Immerse yourself with us in the fascinating world of innovations and exciting developments in medical technology.

February 21, 2024

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.

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.

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.

Market & Industry

seleon GmbH becomes part of the aesco solutions group

Investment in strengthening the MedTech CDMO location in Europe / Expansion of the service and technology portfolio / Successful step in the implementation of the buy-and-build strategy.

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.

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).

February 19, 2024

Medical Apps - the seleon Market Study in the Dach Region

How important are medical apps today? Should they be developed in-house or with external development partners and who is responsible for keeping the app up to date?

February 19, 2024

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.

Jun 20, 2024 10:30 AM - 11:45 AM | Meeting Point: Eingang Halle 1 (Entrance Hall 1)

Past events (3)

Guided Tour

Jun 19, 2024 1:30 PM - 2:45 PM | Meeting Point: Eingang Halle 1 (Entrance Hall 1)

Guided tour "digitalization"

MedtecLIVE 2024

Guided Tour

Jun 19, 2024 1:30 PM - 2:00 PM | Exhibitor Forum (1-916)

Development & production of innovative medical products

MedtecLIVE 2024

Exhibitor Presentation