Regulatory approvals are required by Health Canada, FDA, and CE as a measure to provide a high level assurance that design and manufacture of devices consistently meets required specifications and to minimize the occurance of problems/defects. Generally quality systems are designed to increase the assurance of safety and effectiveness of medical devices. Low Intensity Laser Therapy is an accepted therapy by Health Canada. The BioFlex System has demonstrated clinical efficacy and compliance with all required safety standards and is UL and CSA approved.

The BioFlex System uses class 3B lasers which can be hazardous if viewed directly. Safety measures are as follows:
· wearing safety glasses
· never point laser at eyes
· only certified personnel may operate laser
· displaying laser sign outside treatment rooms