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.