Has any US Medical Device maker here joined MDSAP yet?

M

MIREGMGR

#1
Supposedly this multinational replacement for VARSP started up last January, but my understanding is that only a few NBs operating within USA are qualified to participate so far, and BSI Americas (for instance) just did their first trial audit with FDA observers (to judge the audit team, not the subject company) in August.

My further understanding is that this is intended to be the future of FDA ordinary random (i.e. QSIT 1) audits, with the FDA inspector corps being re-focused only on For Cause and emergency situations.
 
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