MedSysCon Medizintechnik GmbH

Europe’s IVD Regulation

m3dsyscon — Fri, 21 Mar 2025 07:54:28 +0000

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.

Der Beitrag Europe’s IVD Regulation erschien zuerst auf MedSysCon Medizintechnik GmbH.

FDA’s view on cybersecurity

m3dsyscon — Thu, 20 Mar 2025 07:35:36 +0000

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.

Der Beitrag FDA’s view on cybersecurity erschien zuerst auf MedSysCon Medizintechnik GmbH.

New FDA Guidance on AI enabled Device Software Functions

m3dsyscon — Wed, 19 Mar 2025 07:40:15 +0000

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 ...

Der Beitrag New FDA Guidance on AI enabled Device Software Functions erschien zuerst auf MedSysCon Medizintechnik GmbH.

Medical Device EU Import and Distribution

m3dsyscon — Sat, 15 Mar 2025 07:39:13 +0000

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),

Der Beitrag Medical Device EU Import and Distribution erschien zuerst auf MedSysCon Medizintechnik GmbH.

FDA – Change Control Plans (PCCPs)

m3dsyscon — Fri, 14 Mar 2025 10:49:14 +0000

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, ...

Der Beitrag FDA – Change Control Plans (PCCPs) erschien zuerst auf MedSysCon Medizintechnik GmbH.

Regulatory Guidelines for AI-Driven Medical Devices

m3dsyscon — Tue, 10 Sep 2024 14:11:36 +0000

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 ...

Der Beitrag Regulatory Guidelines for AI-Driven Medical Devices erschien zuerst auf MedSysCon Medizintechnik GmbH.

The impact of the AI Act on Medical Devices

m3dsyscon — Fri, 31 May 2024 15:57:18 +0000

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 ...

Der Beitrag The impact of the AI Act on Medical Devices erschien zuerst auf MedSysCon Medizintechnik GmbH.

Decoding FDA’s Draft Guidance On CSA

m3dsyscon — Thu, 08 Feb 2024 13:04:48 +0000

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 ...

Der Beitrag Decoding FDA’s Draft Guidance On CSA erschien zuerst auf MedSysCon Medizintechnik GmbH.

FDA gives full recognition to AAMI cybersecurity guidance document

m3dsyscon — Wed, 08 Nov 2023 19:37:03 +0000

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.

Der Beitrag FDA gives full recognition to AAMI cybersecurity guidance document erschien zuerst auf MedSysCon Medizintechnik GmbH.

FDA Issues Final Guidance on Cybersecurity in Medical Devices

m3dsyscon — Wed, 04 Oct 2023 18:26:03 +0000

he U.S. Food and Drug Administration (FDA) has recently unveiled its comprehensive final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

Der Beitrag FDA Issues Final Guidance on Cybersecurity in Medical Devices erschien zuerst auf MedSysCon Medizintechnik GmbH.