Medical

EDGE serves the unique medical and life sciences market via our EDGE Medica division. 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 to design transfer to manufacture. Our programs focus on medical devices – including disposable, single use, and mechanical or electro-mechanical devices – and life sciences laboratory instrumentation, leveraging our experience and expertise in biological and chemical detection systems.

Download the 2008 Devices Data Sheet (PDF)
Download the 2008 Life Science Data Sheet (PDF)

Examples of Recent Projects:

• Anthrax DNA Detector
• Needle Free IV Access Device
• Biopsy Device
• Ophthalmic Laser System
• Catheter Based Therapy
• Pharmaceutical Delivery Systems
• Confocal Microscope
• Dialysis Catheter Scanners
• Spinal Disc Fixation System
• Electro Surgical Instruments
• Thermal Ablation Catheter System
• Fluid Warmer

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 a four layer injection molded polystyrene assembly with a silicone valving layer, integrated sterile pump, oxygenation loop, drip detector for closed loop flow control, and optical pH detector. EDGE designed a proprietary embedded controller along with its firmware. The core of the firmware was a flexible, externally editable protocol facility, 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.