21 CFR 820 : Overview of the Main Requirements
The part of the Code of Federal regulation 21 CFR Part 820 is the section related to the requirements for Quality Management System of medical device manufacturers that want to
The New IVDR Classification for In-Vitro Diagnostic Devices
One of the biggest changes introduced with the new IVDR 2017/746 is the classification for IVD products. In fact the classification substantially changes between IVDD and IVDR in order to
The 10 Must-Have Contents for a Quality Plan
Quality Plans are inessential tools for many organisation to manage and handle specific quality projects in an extremely efficient way. If we take the official definition of a Quality Plan
Summary of Safety and Clinical Performance (SSCP) according to EU MDR
As we know, the European Medical Device Regulations introduced in new requirements for medical device manufacturers, especially in the field of post-market surveillance and of these new requirements is related
Software Development Plan According to IEC 62304:2006
The development of software for SaMD (Software As Medical Device) and SiMD (Software In Medical Device) is regulated through a specific standard named IEC 62304 - Medical device software —
