MDR Supports Safe Design

MDR Supports Safe Design

The forthcoming Medical Device Regulation (MDR) has gained a significant amount of attention in industry publications in recent months. The question is, how will it support design teams in ensuring they develop safe medical devices? The good news is that many of the...
Making Sense of PEMS

Making Sense of PEMS

For safety relevant or safety critical medical devices (where section 14 of IEC 60601-1 Programmable Medical Electrical Systems (PEMS) is applicable), system architects and development teams are faced with a daunting list of items to consider in their PEMS...