Performance Evaluation for IVDR FAQ
What documents and resources are needed for performance evaluation requirements under IVDR?
What is involved in the performance evaluation process for IVDs under the IVDR?
We have the answers…
PEP
IVD Performance Evaluation Planning & Report (PER)
Plan for success: IVD Performance Evaluation Process Planning and Report (PER). Due to EU IVDR 2017/746 new requirements are being imposed on IVD manufacturers pursuing CE marking for their devices. Clin-r+ provides insight and guidance in this document.
IVD Performance Evaluation Planning & Report (PER) Read More »
