OpenRegulatory Conference 2021
Natascha Cuper, Kiwa Dare Services
Common Findings in SaMD Applications and Notified Body Expectations
As the first applications for MDR certification have been submitted and the first certificates have been issued, it becomes more clear what manufacturers of SaMD are typically struggling with. In my talk, I will lead you through some common findings we see as a Notified Body and will tell you what our expectations are. This way, start-ups might be able to avoid these errors, helping them to go more smoothly through the certification process.
Natascha Cuper is a Clinical and Technical Product Reviewer at Kiwa Dare Services, a Notified Body in the Netherlands.
She's a Veterinarian by training and did her PhD at UMC Utrecht.