ISO 14644 : Requirements for Cleanrooms
The ISO 14644 family of standards serves as a comprehensive guide for establishing and maintaining cleanroom environments, especially in the…
Trend Reporting According to EU MDR and IVDR
In this comprehensive article, we will delve into the requirements for Trend Reporting as outlined in Article 88 of the…
IEC 82304-1 and its Application for Stand-Alone Software
IEC 82304, in conjunction with IEC 62304, plays a critical role in the realm of software-based medical devices. While these…
