Medsyscon Medizintechnik GmbH

24/03/2025

https://www.medsyscon.com/en/europes-ivd-regulation/

The IVDR introduces a comprehensive risk-based classification system, categorizing devices into four classes: Class A (lowest risk), Class B, Class C, and Class D (highest risk). Higher-risk devices necessitate notified body involvement, adding pressure on regulatory resources.

20/03/2025

https://www.medsyscon.com/en/fdas-view-on-cybersecurity/

The rapid expansion of wireless, internet-connected, and networked medical devices has heightened cybersecurity concerns for manufacturers and developers. As technology evolves, regulators strive to update and maintain security standards to address emerging challenges.

19/03/2025

19/03/2025

https://www.medsyscon.com/en/fda-ai-guidance/

This document provides manufacturers with specific recommendations on how to document AI-powered devices within their marketing submissions. Spanning nearly 70 pages, the guidance is extensive and covers ...

16/03/2025

https://www.medsyscon.com/en/eu-import-and-distribution/

MDCG 2021-23 serves as an essential guidance document for economic operators navigating Article 16 requirements under MDR and IVDR. It offers clarity on compliance obligations related to relabeling and repackaging, emphasizing the necessity of a quality management system (QMS),

16/03/2025

https://www.medsyscon.com/en/blog-ai-driven-regulations/

AI-assisted medical devices have actually existed for some time in the healthcare industry, predominantly in the fields of radiology, cardiology, and general practice/internal medicine.1 Computer-aided detection (CAD) software from ...

16/03/2025

https://www.medsyscon.com/en/pccp/

In 2024, the FDA released two important guidance documents on Predetermined Change Control Plans (PCCPs), establishing a regulatory framework that allows medical device manufacturers to implement specific, ...

16/03/2025

https://www.medsyscon.com/en/blog-ai-act/

With the publication of the agreed text of the European Union’s long-awaited Artificial Intelligence Act (AI Act) now available (subject to minor linguistic and numbering tweaks), the message to medtech companies is clear: they will need to begin their journey toward compliance by understanding .....

16/03/2025

https://www.medsyscon.com/en/blog-on-csa/

The current state of validation is seen as a hindrance to quicker deployments, with an emphasis on adhering to thorough documentation practices instead of building systems that align effectively with their intended use. A risk-based approach to validation has been around ...

08/11/2023

https://www.medsyscon.com/en/blog-sw96/

FDA grants full recognition to AAMI's pioneering guidance document on medical device cybersecurity, ANSI/AAMI SW96:2023, Standard for medical device security - Security risk management for device manufacturers.

30/10/2023

https://www.medsyscon.com/blog-ki-studie/

Die Studie umfasste 33 Ärzte aus 17 verschiedenen medizinischen Fachrichtungen, die insgesamt 284 medizinische Fragen erstellten. Diese Fragen wurden von den Ärzten subjektiv als einfach, mittelschwer oder schwer klassifiziert und konnten entweder binäre (Ja oder Nein) ...

19/10/2023

https://www.medsyscon.com/blog-ki/

In der heutigen Zeit erleben wir eine rasante Entwicklung in der Medizintechnik und Pharmaindustrie, in der die künstliche Intelligenz (KI) eine immer zentralere Rolle einnimmt. Schon heute formt die Technologie unser tägliches Leben und hat das Potential, ...