FDA recommends that partnerships should be used to better monitor medical device performance once released. The article states knee replacements as an example of an area that uses multiple different medical devices, yet the performance information has not been...
On August 8, 2013, Gretchen Bowker, co-founder and COO of Pearl Pathways, will host a webinar on ComplianceOnline.com reviewing the similarities and differences in the regulatory paths and requirements for drugs, biologics and medical devices. It will discuss the...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
