VDE Medical Devices and Software

2020/12/11 - Safety - Cord Schloetelburg

Electrical Safety for Active Medical Devices: The IEC 60601-1 Standard

Medical devices that have an electrical power source must meet special safety requirements. The standard IEC 60601-1 describes these requirements and is therefore one of the most important and most extensive standards for medical devices.

2020/12/10 - Technical Documentation - Cord Schloetelburg

Technical Documentation of Medical Devices According to MDR

Medical device manufacturers must provide a technical documentation for their products. The technical documentation is a compilation of all relevant documents for a product.

2020/12/09 - Medical Software - Cord Schloetelburg

Medical apps or software: classification and approval as medical device

Software like a medical app that has a medical purpose is legally a medical device. This article gives an overview of the path from a software to a medical device with CE-marking.

2020/12/08 - Clinical Affairs - Cord Schloetelburg

Clinical Evaluation of Medical Devices according to MDR

Manufacturers of medical devices must carry out a clinical evaluation of their products in order to be allowed to market them in Europe. To do this, the manufacturer must use clinical data to check whether the medical device is safe and efficient.

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.