Medical Device Manufacturing

Medical Device Manufacturing

Our FDA-registered medical device contract manufacturing services, certified to ISO 13485:2016 and compliant to 21 CFR Part 820, provide quality-controlled, low-volume electromechanical commercial builds with open, accurate pricing models.

Many of our clients start with us during research and development, but we are experienced starting projects at every point in the product life cycle. No matter the starting point, our manufacturing services work hand in hand with our engineering team through the entire process including transfer to manufacturing, pilot production, and low or high volume commercial medical device manufacturing.

We have a 12,000 ft² facility dedicated to medical device manufacturing in addition to our 21,000 ft² R&D headquarters. Our facilities are two miles apart, making for easy and efficient collaboration.

Clinical and Pilot Builds

It may seem like the goal line is near but transfer to manufacturing is one of the more difficult processes in medical device development. It takes a lot of time and energy to move those last few steps.

Are you ready for transfer to manufacturing? Ready for a pilot build? Does your product work as intended? Is your design and documentation complete and accurate? If everything is working properly, we look for released part and assembly documentation, including:

• Drawings
• Material specifications
• Assembly instructions
• Test procedures
• Bill of Materials (BOM)