Description:
Research and Development Companies are often focused on core technology development and early-stage technology demonstrations. FDI specializes in transitioning these technologies with its proven engineering and regulatory processes to ensure products transfer smoothly through FDA-clearance to commercialization and acquisition by the DoD. Join us on the webinar to discuss FDI’s background, capabilities, and experience with military medical device product development and technology transfer.
We are an FDA-registered, ISO 13485-certified medical device engineering, manufacturing, and technical services company supplying both military and commercial markets. FDI has a dynamic and engaged culture that is passionate about our Vision — to accelerate healing with life-changing medical products and services. Our current products include the DoD’s P2131 Automated Field Steam Sterilizer, the recently FDA-cleared FRONT-LINE Field Sterilizer, the Army’s Field Hospital Potable Water and Wastewater Management System , and Medical Maintenance and Service Kits. FDI has significant experience with class II medical device design/development and with navigating DoD requirements. We are passionate about bringing devices from TRL 4 to TRL 9 (a fielded device in an operational environment). FDI holds a $48M ECAT contract with the Defense Logistics Agency to sell medical devices and repair parts to the DoD.
Speakers:
- Chris Hearp, President
- David Michalik, Engineering Manager