McDougall MedTech is an FDA registered medical device design, development and manufacturing service provider. We provide engineering, quality and regulatory resources, quality systems, and equipment/facility capabilities to complete your full medical device product development across a variety of different medical specialties.
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. A snapshot of our capabilities and historical successes:
