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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.

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.

Medical Software, Workshop - Online Event on October 5th, 2021

Agile Development of Medical Software

Is it true that an agile approach to software development for software that is a medical device cannot be used in compliance with the MDR? The answer is: “No. This is not true.”
Find out more in our online workshop.

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.

2020/12/16 - Post-Market-Surveillance - Cord Schloetelburg

Post market surveillance and vigilance of medical devices according to MDR

Manufacturers of medical devices must monitor their products on the market. The European Medical Device Regulation requires manufacturers to systematically and actively collect information on product use after it has been placed on the European market.

2020/12/15 - Quality Management - Cord Schloetelburg

Quality management for medical devices: ISO 13485

The quality management system is an essential component of a medical device manufacturer. The European Medical Device Regulation (MDR) has increased the importance of quality management even further.

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.

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