In a previous blog we looked at the alphabet soup of acronyms that prescribe the environment in which companies must operate in order to manufacture medical devices that are safe and effective. The ISO 13485 certification is the key standard that reassures consumers, and regulatory authorities, that a company adheres to a series of procedures to ensure the manufacture of quality products that are safe.

Once a company has ISO 13485 in place – for which it must undergo an annual audit – then it is in position to secure accreditation for each of its products. In Europe this is the CE Mark while in the USA it is FDA Approval. In Cape Town this week there were two medical device manufacturers that made advances on the regulatory front.

For the past twelve years DISA Vascular has concentrated on the design and manufacture of innovative products such as stents and catheters for the treatment of coronary artery disease. Dr Greg Starke, CEO of DISA (which, by the way, stands for “Designed In South Africa”), announced that the company had just received the CE Mark for its new Cape Cross balloon catheter. According to Greg, “The new catheter has been completely redesigned to meet the ever-growing needs of interventional cardiologists to treat more challenging lesions.”

At CapeRay we are gearing up for the first audit by SGS, our Notified Body, for ISO 13485 that is scheduled to take place in late April 2012. As part of our preparations for this important milestone we hosted our internal auditor at our factory yesterday. Dr Gerhard Laniewski, who flew down from Johannesburg for the audit, has spent more than ten years assisting companies secure regulatory approval for their medical products. Much of this experience has been acquired with Lodox Systems, the manufacturer of a whole-body digital X-ray device for the trauma and forensic markets.

Gerhard spent the day with Samantha Hewett, our Quality Assurance Manager, going through our business procedures with a fine-tooth comb. Using a 13485 audit checklist, they identified some problems (e.g. we lacked a South African device registration procedure) which we will address via corrective actions in the coming weeks. Encouragingly, at the end of a long day, Gerhard concluded, “CapeRay, you’re on the right track. Now all of you must go ahead and follow the procedures as part of your daily work routine.”