Over the past few months, through the Thema HelpDesk service, we have received numerous questions regarding the international regulation of [...]

There are products with substances, among the so-called 'borderline' substances, for which the identification of the correct legal context is [...]

When discussing product quality, organisational quality cannot be ignored. In a total approach, quality extends to the entire company system, [...]

A Thema expert answers some questions on the topic of Medical Devices quality. Why improve the quality of Medical Devices? [...]

What is Quality System 21 CFR Part 820? FDA 21 CFR Part 820 is a regulatory framework governing the [...]

This article proposes that Medical Device Manufacturers embark on a journey through Europe, America and Asia to discover the main [...]