20
Years of
Experience
15
Market
Introductions
10
Successful
FDA Approvals

Welcome

You are a start-up company with an idea for a medical device, but don't know what it takes to bring it to reality and navigate the regulatory landscape? You have an existing device that you would like to market in the US or Europe, but are unsure of the required documentation? Or maybe you are simply short-staffed and need short or longer-term support throughout the product development process? We can help!

Our Advantages

From simple Class 1 devices to Class 3 lasers and surgical robotics, we have successfully mastered a variety of technical and regulatory challenges.

Early and complete documentation of the design process is essential for successful regulatory approvals, and is the reason behind our long list of successful 510(k), PMA, or CE approvals.

Our 4 step phase-gate product development process ensures that your product is done right and on time, the first time.

From Product Definition, through demonstrating technical feasibility, design and development, to verification and validation.

Testimonials

“Ron led a complex development project and performed at a level which would put him in the upper ranks of project managers with whom I've worked.”

Steve Bott
Alcon

“Ron and his team worked diligently to deliver on time and within budget, and we couldn't be happier with the result!”

Steve Vekasy
Vektek Inc.

About the Company

We have been developing medical devices since 1995.

We comply with all applicable standards and regulations.

We can offer support throughout the complete product development cycle, from project management, risk management, requirements analysis (market requirements, user needs, design inputs), architectural design and systems engineering, and regulatory submissions.

Contact Info