IND and NDA applications: US
The two primary application types for the approval of new drugs: T...
Using Benchmarks to Show Compliance EU MDR and EU IVDR
Benchmarking is a formal procedure of evaluation in a process or s...
Requirements of SSCP (Summary of Safety and Clinical Performance)
What is SSCP? The SSCP (Summary of Safety and Clinical Performance...
Post-Market Surveillance Requirements for Medical Devices
Post-Market Surveillance requirements for Medical devices as per E...
Clinical Trial Phases and Types of Studies
Phases of Clinical TrialsTable 1: The phases, types, and nature of...
