The International Standards Organization (ISO) is a network of the national standards institutes of 162 countries, with its headquarters in Geneva that forms a bridge between the public and private sectors. The ISO enables a consensus to be reached on solutions that meet the requirements of both business and broader society. ISO 13485 encapsulates the requirements for a comprehensive management system for the design and manufacture of medical devices. Although it is a stand-alone document, ISO 13485 is harmonized with ISO 9001 in which there is an emphasis on continual improvement.
Within the European Union (EU) there exists a regulation – known as a Medical Device Directive (MDD) – that stipulates the requirements for a product to be certified with a CE Mark (where CE stands for Conformité Européenne, which is French for “European Conformity”). Medical devices are classified according to their risk profile, from least (Class I) to greatest (Class III), with each having its own MDD. In the USA a medical device needs to be approved by the Food and Drug Administration (FDA) and, while this approval is not exactly equivalent to the CE Mark, they are similar. For the past 20 years the Global Harmonization Task Force has been striving towards greater conformity between the different regulatory systems.
For CapeRay, securing ISO 13485 and the CE Mark is a sine qua non, and we are well on our way with the recent appointment of SGS as our Notified Body, to serve as our auditors. We have also just appointed Obelis as our European Authorized Representative, our primary contact with EU competent authorities, who will keep a copy of the technical documentation of our products.
A year ago the FDA announced that digital mammography devices had been re-classified, from Class III to Class II, thus making it simpler to market our PantoScanner platform in the USA. Opportunity knocks for CapeRay.