ASM Hasan Mahmood Ph.D. — 510(k) & Post-market Consultant (Cardiovascular/Ophthalmic)
Manager II, Global Regulatory Affairs
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 File...
Experience: 8+ years
Submissions: 8 510(k)
Expertise & Specializations
Regulatory Pathways
Device Specialties
Regions Served
ASM Hasan Mahmood Ph.D. provides regulatory consulting services to clients in:
Credentials & Recognition
Education & Credentials
Possesses a Ph.D. in Pharmacology/Neuroscience Research from the University of Louisiana Monroe, complemented by an MBA in Marketing & Human Resource from the University of Dhaka and Master's and Bachelor's degrees in Pharmacy. This robust academic foundation, including a high GPA and extensive research publications, provides a strong scientific and business acumen that directly supports a deep understanding of complex medical device and pharmaceutical regulations.
Authored 16 research papers in accredited peer-reviewed journals with significant impact factors during doctoral studies, showcasing a strong commitment to scientific advancement and knowledge dissemination within relevant fields.
Professional Experience
An accomplished Regulatory Affairs Professional with over 13 years of progressive experience, including senior roles at Johnson & Johnson and Alcon, focusing on medical devices and pharmaceuticals. Demonstrated expertise in authoring and successfully remediating numerous US FDA 510(k) submissions and EU MDR Technical Files across various device classes. Proven ability to secure substantial regulatory approvals, enhance product market access, and lead cross-functional teams through complex regulatory challenges, ensuring alignment with global standards.
Enterprise experience
Executive Summary
Professional Overview
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 auth...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.
Cruxi Independent Snapshot
Best suited for
- • MedTech companies seeking expert regulatory guidance
Experience signals
- Regions: US, EU, LATAM, APAC, MEA
- Background: 8+ years of regulatory experience.
Cruxi view
Dr. Mahmood is a uniquely valuable asset for medtech companies, bringing over 8 years of specialized experience in navigating complex US FDA and EU regulatory landscapes. His proven track record includes authoring and securing clearance for numerous 510(k) submissions and successfully remediating technical files for EU MDR compliance across Class I, II, and III devices. What truly sets him apart is the powerful combination of a scientific Ph.D. and a strategic MBA, honed through senior roles at industry leaders like Johnson & Johnson and Alcon. This dual expertise allows him to craft sophisticated regulatory strategies that are not only scientifically sound but also commercially astute, ensuring a clear and de-risked path to market for innovative technologies in cardiovascular, orthopedic, and ophthalmic fields.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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