Bridging the Gaps: Clinical Data for GSPRs

Bridging the Gaps: Determining Clinical Data Sufficiency to Demonstrate Conformity with GSPRs What do I do if there is no data for my device? This is a concern we hear […]
EU MDR and Clinical Evidence: What You Need to Know
“One of the key objectives of the new EU MDR is to ensure a high level of health and safety protection for EU citizens. Making clinical investigation and evaluation requirements […]