Simplifying Global Compliance
The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs
MHRA Tells Devicemakers to Balance Risk With Need to Show Efficacy
Dec. 27, 2013
Medtech sponsors should balance the need to demonstrate safety and efficacy with the potential risks to patients when determining the size and duration of a clinical trial, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. The guidance is one of five released this month on acceptable risks and benefits in device development.
International Medical Device Regulatory Monitor
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