What services does OMID SOURESRAFIL offer?

OMID SOURESRAFIL offers Regulatory Pathway Assessment, Classification Assessment, Predicate Analysis, Test Strategy, 510(k) Authoring & Submission, De Novo & PMA Strategy and other regulatory consulting support depending on project needs.

What pathways does OMID SOURESRAFIL support?

OMID SOURESRAFIL supports 510(k), De Novo, PMA, IDE, Post-market and related FDA lifecycle activities.

What specialties does OMID SOURESRAFIL work in?

OMID SOURESRAFIL commonly supports Cardiovascular, Neurology, Orthopedic, Radiology device areas.

What regions does OMID SOURESRAFIL serve?

Regions served include: United States (FDA), European Union (MDR/IVDR).

How much regulatory experience does OMID SOURESRAFIL have?

OMID SOURESRAFIL has 25+ years in regulatory and quality work.

OMID SOURESRAFIL — 510(k) & De Novo Consultant (Cardiovascular/Neurology)

Independent Regulatory, Clinical & Product Development Consultant

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-e...

Experience: 25+ years

Submissions: 50 510(k), 10 De Novo, 5 PMA

Expertise & Specializations

Regulatory Pathways

510(k)De NovoPMAIDEPost-market

Device Specialties

CardiovascularNeurologyOrthopedicRadiology

Regions Served

OMID SOURESRAFIL provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Credentials & Recognition

Education & Credentials

Holds a PhD in Biomedical Engineering and a Bachelor of Engineering in Electrical Engineering from the University of New South Wales, Australia. Further enhanced expertise with a Certificate in Artificial Intelligence in Healthcare from MIT Sloan School of Management. This robust academic foundation provides a deep understanding of engineering principles and cutting-edge healthcare technologies, crucial for navigating complex medical device regulations.

Authored and prosecuted multiple patent applications in neuromodulation and resorbable implants. Contributed over 28 peer-reviewed papers and abstracts to leading publications in cardiovascular and interventional radiology, heart rhythm, and related fields, showcasing significant contributions to medical device innovation and research.

Certifications

Artificial Intelligence in Healthcare
MIT Sloan School of Management
2023

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)

Professional Experience

A distinguished leader with over 25 years of experience in medical device regulatory, clinical, and product development. Has a proven history of leadership at companies like Smiths Medical and as CEO of startups such as Smart Implant Systems Inc. and EmboMedics. Successfully managed and contributed to numerous Class II/III implantable and electroceutical device projects across diverse therapeutic areas. Demonstrates extensive experience in leading global regulatory approvals and clinical strategy development.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510(k)De NovoPMAIDEPost-market

Device Specialties

CardiovascularNeurologyOrthopedicRadiology

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.

De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Post-Market Support
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
Background: 25+ years of regulatory experience.

Cruxi view

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.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

Contact OMID SOURESRAFIL

Share a brief overview of your device and timeline. Cruxi will forward your request to OMID SOURESRAFIL and help structure next steps.

Contact Now