Medical

Medical Devices: ISO 10993-1:2025 finally released, 6th edition of the standard on Biological risk evaluation...

by Gabriele Pincitore|25 November 20254 December 2025|Blog, Medical, Normativa

ISO 10993-1:2025 update has been published 7 years after the previous edition on November 18,...

Advertising for Medical-surgical Aids (PMCs) and other healthcare products (such as medical devices and diagnostic...

Medical Devices: FDA Draft Guidance on Quality Management System Regulation (QMSR) The FDA has published...

by Gabriele Pincitore|28 October 202528 October 2025|Blog, Medical

In recent months, we have noticed that one of the most frequently asked questions from...

Medical Devices: Consultation Open: EU seeks to simplify MDR and IVDR Frameworks The European Commission...

by Gabriele Pincitore|23 September 202529 September 2025|Blog, Medical, Newsletter

On September 12, 2025, the DG Health and Food Safety of the European Commission officially...

by Gabriele Pincitore|15 July 202515 July 2025|Blog, Medical

Decision (EU) 2025/1324 — Published on 7 July 2025 The European Commission has adopted Decision...

by Gabriele Pincitore|18 June 202518 June 2025|Blog, Medical

Regulation (EU) 2017/745 on medical devices aims to raise the quality and safety standards of...

by Gabriele Pincitore|20 May 202527 November 2025|Blog, Medical

Iso 10093:1-2025 is out! Check out the new standard. On May 1, 2025, the amendment...

1 2 3 … 5 6 Next