EDGE Medica is a division of EDGE that specializes in the medical and life sciences market. EDGE Medica adheres to FDA CFR Title 21, Part 820 Design Controls and Quality Systems Regulations.

EDGE Medica is the ideal partner for proof-of-concept and engineering prototypes for investigation and assessment, or for device development under FDA design controls and design transfer to manufacture. Our programs focus on medical devices - including disposable, single use and mechanical or electro-mechanical devices. We also develop life sciences laboratory instrumentation, leveraging our experience and expertise in biological and chemical detection systems.

Download the 2009 Devices Data Sheet (PDF)

Download the 2009 Life Sciences Data Sheet (PDF)

Examples of Recent Projects

Project Spotlight

Tissue Genesis Inc.

The TGI BOS program was a multi-disciplined development program from concept to low volume production of alpha prototypes. The key challenge was the design of the disposable to control the flow of nutrients and antibiotics to the bio-reactor. The disposable comprised of a four layer injection molded polystyrene assembly with a silicone valve layer, integrated sterile pump, oxygenation loop, drip detector for closed loop flow control, and an optical pH detector.

EDGE designed a proprietary embedded controller along with its firmware. The core of the firmware was a flexible, externally editable protocol factuality, which was used to control the various bio-reactor sequences. The program included the development of a docking station with hot swap capability and system communications to a standard Windows PC to upload data logs and other system information and download protocols and direct commands.