CapeRay’s mission is to: (1) design, develop, manufacture, supply and service medical imaging equipment for the diagnosis of breast cancer; (2) determine the requirements and specifications for these products based on detailed market research that assesses the unmet needs of end users; (3) build these products to meet the highest quality standards; (4) ensure the risk of harm to both patients and end users is as low as possible so that the diagnostic benefits of the products outweigh the associated risks; (5) follow an iterative process of product improvement that incorporates feedback from end users while also minimising the cost of manufacture; and (6) invest in cutting edge R&D on a continuous basis.
Yesterday marked an important milestone for the company in meeting mission statement number 3 – building high quality products – when we received the ISO 13485:2016 certificate (click on image at left) from our Notified Body, Underwriters Laboratory (UL). This followed an audit conducted by UL’s Paulius Dambrauskas who, over a four-day period in late April, explored every detail in our quality management system (QMS).
Our Quality Assurance Manager, Natasha Steele, was understandably upbeat, “Obtaining our certificate was a great achievement for us all at CapeRay. Knowing that quality assurance is an important part of this innovative machine, and meeting quality standards is integral to our success, which made all the hard work worthwhile.” She went on to say, “To comply with all regulatory requirements is a long and difficult road, and I am proud of what our team has achieved. We have an exciting road ahead of us at CapeRay as we continue to build world class and high quality machines for the early detection of breast cancer.”
As the 19th century art critic John Ruskin famously said, “Quality is never an accident. It is always the result of intelligent effort.”