OMID SOURESRAFIL
25+ Yrs MedTech Leader: Regulatory, Clinical, Product Dev, AI, SaMD, Cybersecurity. Global Approvals.
A visionary leader in medical device regulatory, clinical, and product development with over 25 years of extensive experience. Omid excels in navigating the complexities of Class II/III implantable and electroceutical devices across diverse fields including cardiovascular, neuromodulation, neurovascular, orthopedic/spine, interventional radiology, and robotic surgery. His expertise spans cutting-edge areas like sensors, SaMD, cybersecurity, artificial intelligence, and predictive analytics, consistently driving rapid development and achieving global regulatory approvals. Omid's proven track record in securing 510(k), De Novo, PMA, and IDE clearances, alongside CE marking and EU MDR compliance, makes him an invaluable asset for bringing innovative medical technologies to market.
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), De Novo, PMA
Device Types Supported:
SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
25
Num510k Submitted:
50
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, neurology, orthopedic, radiology
Technology Types:
samd, ai_ml, implantable, combo_product
Accepting New Clients:
No
