iV PASS is a regulatory consulting company dedicated exclusively to In Vitro Diagnostic Medical Devices.
Our mission is to assist our clients in their regulatory strategy, and to provide regulatory writing, audit and training services for CE MARKING of IVDMDs manufactured on an industrial scale, and for regulatory compliance of IVDMDs manufactured and used on a non-industrial scale by health institutions.
TECHNICAL DOCUMENTATION REGULATORY COMPLIANCE
QMS REGULATORY COMPLIANCE
REGULATION (EU) 2017/746