Medical

by Gabriele Pincitore|24 Marzo 202624 Marzo 2026|Blog, Medical

For decades, many medical device manufacturers have relied on USP Class VI certification when selecting...

by Gabriele Pincitore|17 Febbraio 202617 Febbraio 2026|Blog, Medical

EUDAMED will become mandatory from May 2026. The European Database on Medical Devices, a key...

Medical Devices: FDA’s SaMD Clinical Evaluation Guidance withdrawn The FDA revised its guidelines in 2026...

by Gabriele Pincitore|20 Gennaio 20265 Febbraio 2026|Blog, Medical

Clinical evaluation remains one of the most critical and challenging elements of medical device compliance....

by Gabriele Pincitore|23 Dicembre 20259 Gennaio 2026|Blog, Medical

The EU Medical Device Regulation (MDR, EU 2017/745) defines the regulatory framework for the design,...

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

by Gabriele Pincitore|25 Novembre 202512 Marzo 2026|Blog, Medical

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

Il 21 Luglio 2025 è stata pubblicata una nuova linea guida che va a regolare...

Medical Devices: FDA Draft Guidance on Quality Management System Regulation (QMSR) The FDA has published...

by Gabriele Pincitore|28 Ottobre 202517 Marzo 2026|Blog, Medical

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