On April 26, 2024, the International Medical Device Regulation Forum (IMDRF) published "Essential Principles of Safety and Performance of Medical [...]
Thema CORP, the US-based Thema subsidiary, is pleased to announce its recent membership in the Philadelphia Chamber of Commerce and LSPA, [...]
A Thema expert answers some questions on the topic of Medical Devices quality. Why improve the quality of Medical Devices? In [...]
This white paper discusses the topic of artificial intelligence, giving definitions, describing its main applications in general, focusing on those [...]
This White Paper provides a comprehensive overview of the marketing of Medical Devices in the USA, focusing on device classification, [...]
On March 20, 2024, the Agência Nacional de Vigilância Sanitária (ANVISA) officially extended the validity of Brazilian Good Manufacturing Practice [...]
In March, the Medical Device Coordination Group (MDCG) published the Guidance on the content of the Clinical Investigation Plan for [...]
On March 20, 2023, Regulation 2023/607 was published in the Official Journal of the European Union - EUR-Lex (Regulation (EU) [...]
The MDR(EU) 2017/745 on Medical Devices introduced several new features and added stricter requirements than in the previous directives, which is [...]
With the MDR Regulation, it is strongly discouraged to assume that nothing has changed. The MDR gave the Notified Bodies a [...]
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