New EU guidance tells notified bodies they must wait to issue a certificate for a high-risk IVD in cases where a similar product is under review by an expert panel.
New EU guidance tells notified bodies they must wait to issue a certificate for a high-risk IVD in cases where a similar product is under review by an expert panel.
In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing. We hope you find it insightful. For questions, please contact info@criterionedge.com.
ABOUT