VDE Medical Devices and Software

2020/12/07 - Usability - Cord Schloetelburg

Usability Engineering for Medical Devices: IEC 62366

Inadequate usability of medical devices can lead to misuse and thus to harm or even death of patients. This also applies to software as a medical device. For this reason, manufacturers of medical devices are obliged to carry out a development process that is linked to usability engineering.

2020/12/04 - Medical Software - Cord Schloetelburg

Software Life Cycle for Medical Devices: IEC 62304

In this article, we discuss what manufacturers must pay attention to when considering the software lifecycle and how the standards specifically help in this respect.

2020/12/03 - Risk Management - 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.

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.

Postponed to 2021: VDE Medical Software

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.

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 smartphone showing the symbols of a microphone, a loudspeaker and a voice recognition software. On the left hand a speech bubble out of face silhouette, on the right side a speech bubble from the smartphone app. Symbolizing increased patient compliance for patient diaries for telemonitoring through speech recognition. A smartphone showing the symbols of a microphone, a loudspeaker and a voice recognition software. On the left hand a speech bubble out of face silhouette, on the right side a speech bubble from the smartphone app. Symbolizing increased patient compliance for patient diaries for telemonitoring through speech recognition.

Improving Patient Compliance With Speech Recognition

The use of patient diaries for telemonitoring often fails due to a lack of compliance. The use of speech recognition can increase patient compliance.

A hand with a red hose leading to a blood icon, a hand with a smart phone and a diagram and a certificate saying "compliance". Symbolizing MDR compliance for medical apps. A hand with a red hose leading to a blood icon, a hand with a smart phone and a diagram and a certificate saying "compliance". Symbolizing MDR compliance for medical apps.

[Video] How to Achieve MDR Compliance for Medical Apps

It’s hard to achieve MDR compliance when developing medical apps. Learn in this presentation how to overcome this hurdle.