Medical Device QA & RA Articles Written By Emergo Group

These articles on medical device quality assurance or regulatory compliance issues have been written by Emergo Group. All articles are copyrighted by Emergo Group.

CE MARKING


FDA 510(k) APPROVAL (CLEARANCE)


DEVICE CLASSIFICATION


LABELING AND TRANSLATION


MISCELLANEOUS


QUALITY SYSTEM COMPLIANCE


REGULATORY SUBMISSIONS


RISK MANAGEMENT


SURVEILLANCE & VIGILANCE