Compliance. It’s a word most engineers and designers hate. The folks at Rainer Technology Ltd., a medical engineering service provider in the U.K., know all too well that staying on top of regulatory compliance can be a complex task. However, there is a good kind of compliance, too, which relates to a new product that Rainer Technology developed. To deal with both kinds of compliance—the governmental and the functional--in the development of the Compliant Artificial spinal disc (CAdisc)—a polyurethane-polycarbonate synthetic spinal disc replacement—it turned to PTC to provide software solutions that would help manage the regulatory process, while at the same time speeding product development.

The company is using PTC’s Windchill PLM software to manage the complexities of developing CAdisc, which will help victims of degenerative disc disease who normally have to undergo complex surgical procedures that involve extensive rehabilitation. The idea behind CAdisc is to provide a solution that requires less rehabilitation, allowing the patient to return to normal physical activity faster, reducing medical care costs.

“We believe the combination of Windchill with the PTC Medical Device Template…is the best solution to help us meet the requirements for compliance to strict design controls, device history file and regulatory requirements within the medical device industry,” says Rob Snell, technical director at Rainer Technology.

Rainer has received the green light to start clinical trials on CAdisc in the U.K.