Zamir Bar-David
35+ year RA/QA expert & ex-Notified Body Auditor specializing in global submissions (FDA, EU MDR, MDSAP) & QMS for...
Zamir Bar-David is a seasoned regulatory and quality consultant with 35 years of experience in the medical device and pharmaceutical industries. Holding a Master's in Business Operations and a B.S. in Engineering, he leverages his background as a former Lead Auditor for Notified Bodies (Intertek, TUV Rhineland) to provide expert guidance. Zamir specializes in global product registrations across 60 countries, with deep expertise in US FDA submissions (510k), EU MDR/IVDR technical documentation, MDSAP, and QMS development (ISO 13485). His mission is to support start-up, small, and large medical device companies in building robust regulatory infrastructures, navigating compliance challenges, and expanding into global markets.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k)
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
35
Ex FDA:
No
Ex Notified Body:
Yes
Ex Big Medtech:
Yes
Device Panels:
orthopedic, general_surgery, anesthesiology, ivd, cardiovascular, other
Technology Types:
samd, implantable, ivd_test
Accepting New Clients:
Yes
