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2020/12/14 - Regulatory Affairs - Cord Schloetelburg

The EU Medical Device Regulation (MDR): What is changing?

The European Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) and the Directive on Active Implantable Medical Devices (AIMDD). This article provides an overview of the major changes and the current status of implementation.

A hospital in the background, a patient and a medicin in the foreground and a big datasheet, symbolizing Medical Device Clinical Trials A hospital in the background, a patient and a medicin in the foreground and a big datasheet, symbolizing Medical Device Clinical Trials
2022/03/09 - Clinical Affairs - Updated: 2022/03/11 - Thorsten Prinz

Medical Device Clinical Investigations

Medical device clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges.

Efficient market access for artificial intelligence (AI)-based software: BAIM

Provided that an AI-based software has a medical intended purpose, it is subject to the regulations 2017/745 (MDR) or 2017/746 (IVDR) in the EU. To help manufacturers of AI-based software in medicine dealing with the ever-increasing stringent requirements for market access, the VDE has developed the regulatory approach “BAIM – Boost AI to Market”. In this blog post we explain the respective background.

EU Regulatory Affairs and Liability Risks of AI-based Medical Devices

Manufacturers of medical devices based on artificial intelligence (AI) technologies are facing two major regulatory challenges in Europe: The fulfillment of the fundamental regulatory requirements for medical devices focusing on software and the Integration of special requirements for AI-based devices into the quality management system.

CE roadmap for medical devices: What are the requirements for approval and what are the costs?

Every time a medical device is developed, the question comes up at some point which regulatory requirements have to be fulfilled. If the new medical device is to be marketed in Europe, it requires a CE marking, i.e. the requirements of the European Medical Device Regulation (MDR) apply.

Cybersecurity-Risk-Management for Medical Devices: ARGOS

We help you to integrate your cybersecurity management into your risk management. In cooperation with you, we establish fast, simple and user-friendly processes with which you can independently examine your product not only for physical hazards in terms of operational security, but also for weak points in information security and eliminate them.

2021/06/10 - Cybersecurity - Hans Wenner

Cybersecurity: US President Biden signs Executive Order

The U.S. President has signed an Executive Order to strengthen the cybersecurity of government entities. The implications extend beyond government entities.

Next-level security for AI-based software as medical device

To prove the safety and performance of AI-based software as a medical device, there are special documentation requirements due to data management and model development.

NB’s New Requirements for AI-based Software

Notified Bodies have published a question catalog for medical devices with AI-based software. To meet the requirements, manufacturers should complement their processes.

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