Medegen is committed to improving patient outcomes
and reducing cost of care through the continual introduction
of quality products that make a difference, continued
education of the healthcare worker on best practices, continued
support of research, and studies to reduce healthcare acquired
infections.

Our Quality policy and goal is to consistently meet our customer's
requirements. The safety and performance of our products are
the result of the effort of all members of the organization and
their support of our quality system.

Medegen is highly committed to quality and compliance meeting
the following certifications and performance requirements:

 NSAI ISO 13485:2003
NSAI ISO 13485:2003
 NSAI ISO CAN/CSA 13485:2003
NSAI ISO CAN/CSA 13485:2003
 Medical Device Directive 93/42/EEC (CE)
Medical Device Directive 93/42/EEC (CE)
 Certificate of CE Registration (MDSS)
Certificate of CE Registration (MDSS)
 FDA Registered Device Manufacturer (Ontario, CA)
FDA Registered Device Manufacturer (Ontario)
 FDA Registered Device Manufacturer (Mexico)
FDA Registered Device Manufacturer (Mexico)