Predictable Medical Device Development

 

Developing a medical device involves a lot more than just having a design and a physical prototype. McDougall has the proven capability to plan and execute the FULL device development process aligned with FDA, ISO, MDR requirements to take your concept/your design and refine, verify and validate it, while at the same time creating your full Design History File, completing your regulatory clearances, and qualifying your manufacturing process for a smooth transition into commercialization. We take on as much or as little of the development as desired and work closely with our clients throughout the process.

 

Please contact us at info@mcdougallmedtech.com. We are excited to learn about your device and prepare a comprehensive plan for you to complete your device development!