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.
About
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 8
- **510(k)s submitted (self-reported):** 8
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, LATAM, APAC, MEA
- **Client types:** sme, large_medtech, startup
- **Location:** United States (Maryland)
- **Availability:** available_now
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### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Dr. Mahmood's key differentiator is his exceptional blend of deep scientific expertise (Ph.D.), strategic business acumen (MBA), and practical regulatory execution experience gained at top-tier medtech corporations. This rare combination enables him to translate complex technical product details into a compelling and successful regulatory narrative that aligns with commercial objectives. Medtech companies gain a partner who understands the product from the scientific principle all the way to market success.
- **Ideal projects:** The ideal project for Dr. Mahmood involves a startup or established medtech company with a complex Class II or III device, particularly within the cardiovascular, orthopedic, ophthalmic, or neurology sectors. He is perfectly suited for companies preparing for a challenging 510(k) submission, navigating the transition from MDD to EU MDR, or requiring a comprehensive global regulatory strategy for market entry. Firms with innovative technologies, such as implantables, that demand a deep technical understanding to build a compelling regulatory case will benefit immensely from his background. Engage Dr. Mahmood when you need a strategic partner to not only execute a submission but to proactively manage FDA communications, resolve deficiencies, and align the regulatory pathway with critical business milestones.
- **Last analyzed:** Thu Jan 01 2026 22:25:28 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, international, de_novo, 510k-special
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ophthalmic, cardiovascular, general-hospital, regulatory strategy, risk management, clinical evaluation, preclinical testing, quality system implementation, quality management systems, orthopedic, neurology, other
- **Device panels:** cardiovascular, ophthalmic, general_surgery, general-hospital, neurology, orthopedic, other
- **Regulatory pathways:** 510k, post_market, q_sub
---
- **Type:** independent
- **Years of experience:** 8
- **510(k)s submitted (self-reported):** 8
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, LATAM, APAC, MEA
- **Client types:** sme, large_medtech, startup
- **Location:** United States (Maryland)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Dr. Mahmood's key differentiator is his exceptional blend of deep scientific expertise (Ph.D.), strategic business acumen (MBA), and practical regulatory execution experience gained at top-tier medtech corporations. This rare combination enables him to translate complex technical product details into a compelling and successful regulatory narrative that aligns with commercial objectives. Medtech companies gain a partner who understands the product from the scientific principle all the way to market success.
- **Ideal projects:** The ideal project for Dr. Mahmood involves a startup or established medtech company with a complex Class II or III device, particularly within the cardiovascular, orthopedic, ophthalmic, or neurology sectors. He is perfectly suited for companies preparing for a challenging 510(k) submission, navigating the transition from MDD to EU MDR, or requiring a comprehensive global regulatory strategy for market entry. Firms with innovative technologies, such as implantables, that demand a deep technical understanding to build a compelling regulatory case will benefit immensely from his background. Engage Dr. Mahmood when you need a strategic partner to not only execute a submission but to proactively manage FDA communications, resolve deficiencies, and align the regulatory pathway with critical business milestones.
- **Last analyzed:** Thu Jan 01 2026 22:25:28 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, international, de_novo, 510k-special
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** ophthalmic, cardiovascular, general-hospital, regulatory strategy, risk management, clinical evaluation, preclinical testing, quality system implementation, quality management systems, orthopedic, neurology, other
- **Device panels:** cardiovascular, ophthalmic, general_surgery, general-hospital, neurology, orthopedic, other
- **Regulatory pathways:** 510k, post_market, q_sub
---
Key Highlights
- 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
- Dr. Mahmood's key differentiator is his exceptional blend of deep scientific expertise (Ph.D.), strategic business acumen (MBA), and practical regulatory execution experience gained at top-tier medtech corporations. This rare combination enables him to translate complex technical product details into a compelling and successful regulatory narrative that aligns with commercial objectives. Medtech companies gain a partner who understands the product from the scientific principle all the way to mar
Certifications & Trust Signals
- 8 years experience
- 8 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal project for Dr. Mahmood involves a startup or established medtech company with a complex Class II or III device, particularly within the cardiovascular, orthopedic, ophthalmic, or neurology sectors. He is perfectly suited for companies preparing for a challenging 510(k) submission, navigating the transition from MDD to EU MDR, or requiring a comprehensive global regulatory strategy for m
HQ:
United States
Languages:
English
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
