News

In November 2025, the Medical Device Coordination Group (MDCG) released guidance MDCG 2025-8, clarifying how the Master UDI-DI should be assigned to…

ISO/TC 194 has published the long-awaited ISO 10993-1:2025. This standard is relevant for almost all medical devices that come into direct or indirect…

On November 4, the NMPA released the revised “Medical Device Manufacturing Quality Management Specifications” (GMP for medical device in China). The…

In October, the FDA released a new draft guidance outlining which Quality Management System (QMS) details must now be included in Premarket Approval…

The EU Commission has published Implementing Decision (EU) 2025/2078, which amends Decision (EU) 2021/1182 by adding four more harmonised standards…

On October 16 and 17, 2025, the NSF Academy Hamburg welcomed senior leaders and decision-makers from the medical technology sector for this year’s N…

On September 24, 2025, the FDA published its final guidance titled Computer Software Assurance for Production and Quality System Software. This…

We are excited to be part of CySecMed 2025 –the leading expert conference for cybersecurity in medical technology!
On the first day of the event,…

On NSF PROSYSTEM's Social Day, our team stepped away from desks and routines to lend a hand where it was most needed. Split into three groups, we…