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.