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

There are products with substances, among the so-called 'borderline' substances, for which the identification of the correct legal context is not [...]

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

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

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

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

12 February 2024 The profession related to the development and management of regulatory activities in the field of Medical Devices [...]

26 October 2023 Substance-based Medical Devices are specifically regulated by the MDR (EU) 2017/745, starting with the classification in Rule [...]

29 September 2023 What is artificial intelligence? Artificial intelligence (AI) is a branch of computer science dedicated to creating systems [...]

27 July 2023 MDR (EU) 2017/745 describes and elaborates on the structure and minimum content of the Post-Market Surveillance Plan (PMSP) [...]