Post-Market Clinical Follow-up Studies for Medical Devices
PMCF studies are not intended to replace the premarket data necess...
ISO 14971 Risk Management for Medical Devices
This standard specifies terminology, principles and a process for ...
EU Med Devices: Increase in MDR applications
Last year the European commission has collected the data from the ...
Using Benchmarks to Show Compliance EU MDR and EU IVDR
Benchmarking is a formal procedure of evaluation in a process or s...
Clinical Trial Phases and Types of Studies
Phases of Clinical TrialsTable 1: The phases, types, and nature of...
EO Sterilization; EPA Mandate; Alternates from FDA
In April, the U.S. Environmental Protection Agency proposed limiti...
