Mort Minaee

• Over 25 years of multidisciplinary experience in Regulatory, Clinical Affairs and Quality Systems in medical device and IVD industries• Specialized in pragmatic regulatory strategies toward expedient Product Approval paths and Registration Submissions (SRD, IDE/IRB, PMA, 510k, CE)• Demonstrated success in numerous pre-IDE collaborations with FDA• A record of successful US and international regulatory approvals of many in vitro diagnostic (IVD) medical devices, including companion diagnostic devices (CDx)• Represented the regulatory perspective internally and externally, advocating projects pipeline potential and transparent pipeline risks and mitigations• Proven track record in successful FDA GMP, BIMO inspections, development, implementation and ISO registration of multiple QA systems• Track record of success in identifying, attracting, retaining and developing superb QA, Clinical and Regulatory Affairs professionals • Provided regulatory intelligence for sharing across business divisions, coordinated impact assessment and formulating of consistent compliance strategies