Medical Device Adverse Event Reporting Regulations: EU vs. US FDA
Regulatory authorities in both Europe and the United States requir...
Regulatory Compliance Guide for SSCP Professionals
Summary of Safety and Clinical Performance (SSCP) is a new Regulat...
Clinical Evaluation without Clinical Data in the EU
Application of EU MDR Article 61(10) When Clinical Data is Conside...
EU Annual Report on Clinical Evaluation (CECP)
The European Commission (EC) published its first annual report abo...
