Imagine you have developed a new diagnostic system, a portable device that monitors a patient’s blood pressure and transmits the information to her iPhone, and you now want to bring this great idea to market. Unlike those ubiquitous consumer applications (known colloquially as “apps”) that often enjoy overnight success, a medical device must first clear various regulatory hurdles before it can be released to the public. There are two primary requirements, the one dealing with the company that manufactures and supplies the device, and the other with the device itself.
At CapeRay we have been working steadfastly for the past two years to secure the ISO 13485 certification, an international standard that specifies the requirements for a comprehensive management system for the design and manufacture of medical devices. “It’s the foundation to set the quality system against,” says Brad Amundson who works for SGS, one of the Notified Bodies responsible for issuing the ISO 13485. “Depending on where a company’s markets are around the world, they need to have this quality system in place, because after laying the foundation they have to put in regulatory requirements for each particular country where they want to sell medical devices.”
Last week we received official notification from SGS that CapeRay Medical (Pty) Ltd had cleared its first hurdle with the award of the ISO 13485 (click on the certificate at right). We also succeeded in clearing the second hurdle, the award of the CE Mark for our first medical device, the Pandia digital X-ray camera. The CE Mark is a key indicator of our camera’s compliance with legislation of the European Union (EU) that relates to the Essential Requirements of the Medical Device Directive, and means that we can sell the Pandia in all 27 countries that belong to the EU (click on the certificate at left).
We have calculated that it cost us $120,000 to secure the ISO 13485 certification for CapeRay and the CE Mark for Pandia. About half this amount paid for regulatory consultants, fees for testing Pandia and the cost of having our company and its first product audited by SGS, while the balance was for the salaries of our own staff.
Returning to that great blood pressure app of yours, you should be aware that it will take both time and money. At CapeRay we are delighted to have received our wings. We are ready to fly!