Consulting and Services

Learn how experts can help you optimize processes and implement regulatory requirements to achieve excellence in the healthcare industry.

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Posts - that's to be discovered on the topic (9)

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

"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.

Früh Verpackungstechnik AG 1 / 1-328
Best practice

#customercentricity or: What serves my customer?

Früh Verpackungstechnik AG sets standards in individual solutions for medical and pharmaceutical products, thus helping to optimize costs and promote sustainability.

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).

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
Interview

“The industry needs to learn quickly“

Medical devices and systems are becoming increasingly networked and, at the same time, they are processing highly sensitive patient data. There are risks involved because cyber attacks on medical technology are on the increase.

seleon GmbH
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.

seleon GmbH
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.