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.

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.

a fragmented CD symbolizing software segregation a fragmented CD symbolizing software segregation
Medical Software - Updated: 2021/04/16 - Georg Heidenreich and Hans C. Wenner

Software Design for Segregation

Segregation is an important strategy in software development for reducing complexity. Find out how to apply segregation to your software.

A guy showing his hand with some kind of stain on it, a smartphone showing a checkmark. All together symbolizing mole assessment via medical app as an example for risk classification . A guy showing his hand with some kind of stain on it, a smartphone showing a checkmark. All together symbolizing mole assessment via medical app as an example for risk classification .
Medical Software - Updated: 2021/04/16 - Isabel Jakobs and  Ulrich Spiegel

Risk Classification of a Medical App

Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!

A woman wearing a coat, a hat and sunglasses, standing in front of a desk with a locked file on it. Symbolizing trade secrets . A woman wearing a coat, a hat and sunglasses, standing in front of a desk with a locked file on it. Symbolizing trade secrets .
Regulatory Affairs - Updated: 2021/04/16 - Janine Manke and Daniel Kendziur

Trade Secrets: Protect Your Intellectual Property

You must understand the importance of protecting your trade secrets or the development of your medical software was useless!

Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine . Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine .
2019/05/02 - Artificial Intelligence - Updated: 2021/04/16 - Thorsten Prinz

Market Access for Artificial Intelligence in Medicine

How does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.