Product validation and verification: The information provided in the product validati ...

Clinical evidence: The dossier should contain the clinical evidence that demonstrates ...

This summary may include: (a) Where a recognized standard exists, a declaration/certi ...

Sponsor or manufacturer Name and address of the sponsor or manufacturer of the inves ...

7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstr ...

(B) Such summary information may include: (i) declaration or certificate of conformit ...

Studies: This section of PSUR shall capture the brief summary of clinically important ...

7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...