From prototype to FDA clearance, with one team.
Engineering, quality and regulatory experts who work as your own department.
- 510(k), De Novo and Pre-Sub support
- ISO 13485 and FDA QMSR quality systems
- U.S. Agent for international companies
- Concept
- Design & test
- Submit
- Launch
One team for the whole device
Most 510(k)s that stall with FDA have engineering gaps, not paperwork gaps. We cover both, so nothing falls between vendors.
Regulatory
Find the right FDA pathway and get through review.
- FDA pathway and classification
- Pre-Submissions
- 510(k) and De Novo submissions
Engineering
Design, test and manufacture a device that holds up.
- Mechanical, electrical and software design
- Verification and validation
- Manufacturing transfer
Quality
The quality system FDA expects, sized for your stage.
- ISO 13485 and FDA QMSR
- Design controls and risk management
- Audit and inspection readiness
Led by engineers who have built medical devices
Matt Aria, PhD, PE, PMP
Founder and principal consultant
More than 20 years in multidisciplinary engineering, product development and technical leadership, with experience spanning patient monitoring, respiratory technologies, wearable sensors, CGM, insulin delivery, infusion systems, and medical device quality and regulatory strategy.
Electrical, software and industrial design engineers, plus quality and supplier quality specialists.
Meet the teamWho we work with
Startups
No engineering, quality or regulatory team yet? We become yours, from first prototype to clearance.
Check your FDA pathwayInternational companies
Bring your device to the U.S. with a clear FDA plan, a U.S. Agent and lower small business fees.
How U.S. entry worksEstablished companies
Add senior engineering, quality or regulatory capacity for a specific project, by the hour.
See hourly ratesTalk to an engineer, not a salesperson
Tell us about your device. We'll tell you the fastest route to FDA.