Company profile
RegMedAI
Simplifying FDA compliance for AI-enabled medical devices. Delivering predictable clearance.
- Industry
- Medical Equipment Manufacturing
- Employees
- 2
- Headquarters
- New York City( We are Fully Remote)
- Founded
- 2025
- Office locations
- 1
RegMedAI company summary
RegMedAI is a company in the Medical Equipment Manufacturing industry, headquartered in New York City( We are Fully Remote), founded in 2025. On LinkedIn the company has around 2 employees. Its listed specialties include PCCP, FDA 510(k) Submission, AI/ML SaMD Strategy, FDA De Novo Request, FDA Deficiency Response (AINN).
What technology does RegMedAI use?
No technologies detected yet. Warmrank rechecks company websites on a rolling basis.
About RegMedAI
At RegMedAI, we specialize in simplifying FDA compliance for AI-enabled medical devices (SaMD). You focus on innovation while we ensure full regulatory compliance and accelerate your FDA clearance—from regulatory strategy to submission—with confidence. Led by former FDA and industry veterans, we provide unmatched regulatory expertise and end-to-end support for AI/ML SaMD. We utilize a focused engagement model designed to maximize your likelihood of clearance while significantly reducing costly rework. Ready to accelerate your path to market? Partner with us today to streamline your submission.
Specialties
Where is RegMedAI located?
RegMedAI lists 1 location.
Compare companies similar to RegMedAI
More companies in Medical Equipment Manufacturing.
| Company | Industry | Employees | Founded | Headquarters |
|---|---|---|---|---|
RegMedAI regmedai.com | Medical Equipment Manufacturing | 2 | 2025 | New York City( We are Fully Remote) |
 Boston Scientific bostonscientific.com | Medical Equipment Manufacturing | 54,970 | - | Marlborough, MA |
 BD bd.com | Medical Equipment Manufacturing | 46,224 | - | Franklin Lakes, New Jersey |
 Baxter International Inc. baxter.com | Medical Equipment Manufacturing | 39,218 | - | Deerfield, Illinois |
 Alcon alcon.com | Medical Equipment Manufacturing | 27,667 | - | Geneva, Switzerland |
 Smith+Nephew smith-nephew.com | Medical Equipment Manufacturing | 19,271 | - | Watford, Hertfordshire, GB |
 Zimmer Biomet EMEA zimmerbiomet.com | Medical Equipment Manufacturing | 19,125 | - | Warsaw, Indiana |
 Olympus Corporation olympus-global.com | Medical Equipment Manufacturing | 13,703 | 1919 | Shinjuku-ku, Tokyo |
 Intuitive intuitive.com | Medical Equipment Manufacturing | 13,091 | 1995 | California, 94086 |
 Medline Australia medline.com | Medical Equipment Manufacturing | 18,899 | - | Northfield, IL |
 Edwards Lifesciences edwards.com | Medical Equipment Manufacturing | 14,197 | 1958 | Irvine, CA |
Frequently asked questions about RegMedAI
What does RegMedAI do?
At RegMedAI, we specialize in simplifying FDA compliance for AI-enabled medical devices (SaMD). You focus on innovation while we ensure full regulatory compliance and accelerate your FDA clearance—from regulatory strategy to submission—with confidence. Led by former FDA and industry veterans, we provide unmatched regulatory expertise and end-to-end support for AI/ML SaMD. We utilize a focused engagement model designed to maximize your likelihood of clearance while significantly reducing costly rework. Ready to accelerate your path to market? Partner with us today to streamline your submission.
How many employees does RegMedAI have?
RegMedAI has around 2 employees on LinkedIn.
Where is RegMedAI headquartered?
RegMedAI is headquartered in New York City( We are Fully Remote).
When was RegMedAI founded?
RegMedAI was founded in 2025.
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