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A disc falling down, bumping on some pins, finally landing in one of the 4 bowls, labelled I, IIa, IIb and III. Symbolizing software classification according to EU MDR.
Published: 2019/07/11 - Medical Software - Updated: 2019/11/28 - by Tobias Schreiegg and Thorsten Prinz

Software Classification: Insights in EU Guidance

The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline!

Clinical Affairs - by Cord Schloetelburg

Clinical Evaluation of Medical Devices

Get an overview of the most important elements of a clinical evaluation of medical devices according to the EU Medical Device Regulation (MDR).

Usability - by Cord Schloetelburg

Usability Engineering for Medical Devices: IEC 62366

In this article we discuss how Usability Engineering based on IEC 62366 leads to a better and compliant medical device.

Medical Software - by Cord Schloetelburg

Software Life Cycle for Medical Devices: IEC 62304

In this article we give an overview of the software life cycle of medical devices and the corresponding standards.

Risk Management - by Cord Schloetelburg

Risk Management for Medical Devices: ISO 14971

The risks of a medical device must be acceptable in comparison to its benefits. Manufacturers must therefore carry out a risk management process. Read how this works in this article.

VDE Medical Software 2020

The MeSo expert community will meet on 13 May 2020 in Frankfurt. Find out which regulatory requirements you have to meet now and in the future and how to implement them efficiently.

Market Access for Medical Devices and Software

VDE MeSo offers practical support for the approval and certification of medical devices and software. We help you to bring your product to market faster and more efficiently.

a fragmented CD symbolizing software segregation
Published: 2019/10/11 - Medical Software - Updated: 2019/11/28 - by 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!

Person standing, having a a folder with a scale symbol on it, in his hands. In the background some shelves with many books on it. Altogether symbolizin a person taking care of the legal requirements and most importent documents for market access of medical software.
Published: 2019/07/31 - Medical Software - Updated: 2019/12/05 - by Thorsten Prinz

Legal Requirements for Medical Software

Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards.

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