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.
About
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 50
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme, large_medtech
- **Location:** United States (CA)
- **Availability:** available_now
- **Certifications:** Artificial Intelligence in Healthcare, Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), ISO 13485 Lead Auditor & Implementation, Six Sigma Green Belt & Champion, IEC 60601, IEC 62304, ISO 14971 Risk Management, EU MDR, Clinical Evaluation Reports (CER)
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### **Cruxi analysis**
- **Strength summary:** A seasoned expert with 25 years of experience in medtech, Omid Souresrafil excels in navigating complex medical device regulations. With a profound understanding of FDA regulations, including 510(k), De Novo, PMA, and IDE, he has a strong track record of securing global regulatory approvals. His expertise spans cutting-edge areas like sensors, SaMD, cybersecurity, AI, and predictive analytics, making him highly valuable for medtech companies seeking innovative solutions. His achievements in securing 510(k), De Novo, PMA, and IDE clearances, alongside CE marking and EU MDR compliance, demonstrate his ability to drive rapid development and approvals. Moreover, his experience in leading global regulatory approvals and clinical strategy development sets him apart as a trusted advisor for medtech companies.
- **Unique value:** Omid Souresrafil's unique value proposition lies in his combination of 25 years of medtech experience, FDA regulatory expertise, and technical skills in cutting-edge areas like AI, SaMD, and cybersecurity. His ability to drive rapid development and approvals, coupled with his success in securing global regulatory approvals, makes him a trusted advisor for medtech companies seeking innovative solutions and regulatory compliance.
- **Ideal projects:** A medtech company seeking to launch a Class II/III implantable or electroceutical device, particularly in cardiovascular, neuromodulation, neurovascular, orthopedic/spine, interventional radiology, or robotic surgery, would benefit from engaging Omid Souresrafil. His expertise in regulatory pathways, such as 510(k), De Novo, and PMA, makes him an ideal fit for companies at various stages, from startups to large medtech. Projects requiring a deep understanding of medical device regulations, cybersecurity, AI, and SaMD would benefit from his unique combination of technical skills and regulatory expertise. Companies preparing for their first submission or expanding internationally would also benefit from his expertise in EU MDR compliance and Notified Body interactions.
- **Last analyzed:** Sat Dec 20 2025 01:19:14 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, clinical-trials, qms, international
- **Device classes:** class-ii, class-iii
- **Specialties:** cardiovascular, orthopedic, neurology, radiology, software-samd, risk management, clinical evaluation, quality system implementation, quality management systems
- **Device panels:** cardiovascular, neurology, orthopedic, radiology
- **Regulatory pathways:** 510k, de_novo, pma, ide, post_market
---
- **Type:** independent
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 50
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme, large_medtech
- **Location:** United States (CA)
- **Availability:** available_now
- **Certifications:** Artificial Intelligence in Healthcare, Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), ISO 13485 Lead Auditor & Implementation, Six Sigma Green Belt & Champion, IEC 60601, IEC 62304, ISO 14971 Risk Management, EU MDR, Clinical Evaluation Reports (CER)
---
### **Cruxi analysis**
- **Strength summary:** A seasoned expert with 25 years of experience in medtech, Omid Souresrafil excels in navigating complex medical device regulations. With a profound understanding of FDA regulations, including 510(k), De Novo, PMA, and IDE, he has a strong track record of securing global regulatory approvals. His expertise spans cutting-edge areas like sensors, SaMD, cybersecurity, AI, and predictive analytics, making him highly valuable for medtech companies seeking innovative solutions. His achievements in securing 510(k), De Novo, PMA, and IDE clearances, alongside CE marking and EU MDR compliance, demonstrate his ability to drive rapid development and approvals. Moreover, his experience in leading global regulatory approvals and clinical strategy development sets him apart as a trusted advisor for medtech companies.
- **Unique value:** Omid Souresrafil's unique value proposition lies in his combination of 25 years of medtech experience, FDA regulatory expertise, and technical skills in cutting-edge areas like AI, SaMD, and cybersecurity. His ability to drive rapid development and approvals, coupled with his success in securing global regulatory approvals, makes him a trusted advisor for medtech companies seeking innovative solutions and regulatory compliance.
- **Ideal projects:** A medtech company seeking to launch a Class II/III implantable or electroceutical device, particularly in cardiovascular, neuromodulation, neurovascular, orthopedic/spine, interventional radiology, or robotic surgery, would benefit from engaging Omid Souresrafil. His expertise in regulatory pathways, such as 510(k), De Novo, and PMA, makes him an ideal fit for companies at various stages, from startups to large medtech. Projects requiring a deep understanding of medical device regulations, cybersecurity, AI, and SaMD would benefit from his unique combination of technical skills and regulatory expertise. Companies preparing for their first submission or expanding internationally would also benefit from his expertise in EU MDR compliance and Notified Body interactions.
- **Last analyzed:** Sat Dec 20 2025 01:19:14 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, clinical-trials, qms, international
- **Device classes:** class-ii, class-iii
- **Specialties:** cardiovascular, orthopedic, neurology, radiology, software-samd, risk management, clinical evaluation, quality system implementation, quality management systems
- **Device panels:** cardiovascular, neurology, orthopedic, radiology
- **Regulatory pathways:** 510k, de_novo, pma, ide, post_market
---
Key Highlights
- A seasoned expert with 25 years of experience in medtech, Omid Souresrafil excels in navigating complex medical device regulations. With a profound understanding of FDA regulations, including 510(k), De Novo, PMA, and IDE, he has a strong track record of securing global regulatory approvals. His expertise spans cutting-edge areas like sensors, SaMD, cybersecurity, AI, and predictive analytics, making him highly valuable for medtech companies seeking innovative solutions. His achievements in secu
- Omid Souresrafil's unique value proposition lies in his combination of 25 years of medtech experience, FDA regulatory expertise, and technical skills in cutting-edge areas like AI, SaMD, and cybersecurity. His ability to drive rapid development and approvals, coupled with his success in securing global regulatory approvals, makes him a trusted advisor for medtech companies seeking innovative solutions and regulatory compliance.
Certifications & Trust Signals
- 25 years experience
- 50 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- A medtech company seeking to launch a Class II/III implantable or electroceutical device, particularly in cardiovascular, neuromodulation, neurovascular, orthopedic/spine, interventional radiology, or robotic surgery, would benefit from engaging Omid Souresrafil. His expertise in regulatory pathways, such as 510(k), De Novo, and PMA, makes him an ideal fit for companies at various stages, from sta
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, 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
