ISO-13485 Quality System

Solarc Systems believes a strong quality system is essential to the design and manufacture of safe and effective medical devices. 

To ensure this, we have developed and maintained a Quality System recognized by the International Standards Association (ISO). The lofty ISO-13485 Certification is specific to medical device manufacturers, and covers all aspects of the business; from design, procurement, and production all the way to delivery and customer satisfaction. We are subject to many controls; including management reviews, internal audits, and annual 3rd party audits.

What does this mean to you? A consistently high quality product and outstanding service.

We work hard to serve you. Our testimonials speak for themselves.

Click here for more regulatory information, such as Health Canada and FDA requirements.