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The European Union's MDR (EU) 2017/745 requires medical device manufacturers to adopt a systematic Post-Market Surveillance (PMS) process to ensure the [...]

Change management in Medical Devices is essential to ensure European and international compliance. After the product is first placed on the [...]

Machine Learning-Enabled Medical Devices (MLMD) represent a revolution in healthcare. These Medical Devices, based on artificial intelligence and machine learning, assist [...]

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 [...]