ASM Hasan Mahmood Ph.D.
Expert Regulatory Affairs Professional | USFDA Submissions & EU MDR Compliance | Medical Devices & Pharmaceuticals
An exceptionally accomplished Regulatory Affairs Professional with over 8 years of progressive experience in medical devices and pharmaceuticals, adept at navigating complex global regulatory landscapes. Dr. Mahmood possesses a proven track record of securing substantial regulatory approvals by authoring and expertly responding to USFDA premarket submissions (510(k)) and remediating Technical Files for EU MDR compliance across Class I, II, and III devices. His strategic approach and meticulous attention to detail ensure enhanced product market access while upholding critical regulatory standards. With a strong foundation in scientific research and a Master of Business Administration, Dr. Mahmood brings a unique blend of technical expertise and strategic insight to drive regulatory success for medtech companies.
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, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
8
Num510k Submitted:
8
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, ophthalmic, general_surgery, general-hospital, neurology, orthopedic, other
Technology Types:
implantable
Engagement Models:
hourly
Accepting New Clients:
No
