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 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
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
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
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
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