Medical Devices: Product and Organisational Quality
When discussing product quality, organisational quality cannot be ignored. In a total approach, quality extends to the entire company system, is [...]
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) [...]
30 May 2023 General conditions the extension of the transition period Compliance with Directive 90/385/EEC or Directive 93/42/EEC. No significant changes [...]
3 May 2023 After the third extension of MDR (EU) 2017/745, formalised by Regulation 2023/607, it is increasingly difficult for manufacturers [...]