Developing and Maintaining a QMS for IVDs
In vitro diagnostics (IVDs) are crucial for detecting diseases, conditions, and infections through tests conducted outside the human body. The […]
In Vitro Diagnostic Regulation
Understanding the In Vitro Diagnostic Regulation (IVDR)
In Vitro Diagnostic Regulation (IVDR) EU 2017/746 took full effect, replacing the previous Directive, IVDD 98/79/EC. This new regulation significantly