I3CGlobal Introduces early stage audit readiness solutions to streamline ISO 13485 certification for medical device and IVD compani ...

ISO 13485 Implementation vs Certification: Step-by-Step Process Explained ISO 13485 Implementation Process: The implementation of ISO 13485 begins with a gap analysis to compare your current quality ...

This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices.

Zentek is certified under ISO 13485:2016 and focuses on the research ... The company is in the process of finalizing documentation to support the manufacture and sale of these filters under ...

At the heart of any successful initiative is a solid plan. Improvement initiatives require clear objectives and a defined ...

Industry standards for surface finish help define the specifications of the instruments, how they are used, the results they provide and how they can be tested for performance. 26 Feb 2025 Marathon ...

SGS Belgium NV has been officially designated by the European Commission and Belgian Competent Authority as a Notified Body (NB) under the In Vit ...