Home

/

/

[FEATURED] How Notified Bodies Must Ensure Appropriately Qualified Staff Assess Each IVD

Notified bodies must have a system in place to ensure that IVD devices are assessed by individual staff and teams with adequate knowledge and expertise. EU guidance explains the criteria for notified bodies.

About the Blog

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.

Get in Touch

Recent Posts