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CAPERAY MEDICAL

mark, essential for selling equipment in international markets and attracting investors. “In order to be able to sell our systems, both in South Africa and internationally, we need to secure the CE mark and that is issued by the notified body - essentially an auditor,” details Vaughan. “That CE mark audit started in late-January with a specialist company called Underwriters Laboratories who have proved very helpful. They’ve conducted the off-site audit and reviewed the information in our technical file, and the on-site audit will happen in Cape Town in mid-May. We anticipate securing the CE mark in June. As part of the process

to secure the certification, you also have to have the system independently tested and that test report is currently about halfway through. It’s being conducted by a company in the USA and is an expensive process. They test for electromagnetic interference and compatibility, and also safety testing. We had to ship our product to Baltimore and we also sent an engineer out to complete repairs and testing and we hope for that process to be complete by the beginning of June. When these processes are complete, we will be ready to market ourselves and sell systems in South Africa and around the world and that is good news. It’s taken us seven years and almost £3 million

(approx. R45 million) to get to where we are today.” Any future business that CapeRay Medical may achieve will be based on its ability to gain the relevant approvals, endorsements and authorisations from industry bodies, and obtaining these certifications will also bolster the business as an investment case. Fortunately, extensive clinical trialling and testing has already been documented and further trials are set to start in the near future as Vaughan explains. “We are carrying out final tests on a new machine which will be installed into a military hospital in Wynberg, Cape Town. We’re going to run a long-

//HEALTH-WISE: ENSURING QUALITY AND SAFETY COMPLIANCE IN THE MANUFACTURE OF MEDICAL DEVICES Technological innovation in the field of medicine is happening at a pace never seen before, and nowhere is quality and safety control more important than in the manufacture of devices on which lives, health and well-being depend. Equally important, however, is the business need to get fully certified products to market without delay. Balancing these two objectives is one of the greatest challenges facing companies that not only have to invest heavily in research and development, but also have to meet stringent regulatory standards. This is where UL (Underwriters Laboratories), which has over 120 years of experience in testing and certification, is such an invaluable business partner. UL’s Health Sciences teams are amongst the most diverse and experienced in the world, helping manufacturers to get their products to market faster. Using specialist industry teams, we help our customers to meet key milestones in the development of sophisticated medical devices, making sure they conform to regulatory requirements every step of the way. We assist in securing compliance right from concept through to launch and, thereafter, help to maintain it throughout the lifecycle of the product. If regulatory requirements are not met at all of stages of the product lifecycle, this could lead to costly delays or even embargoes, bans, recalls and liability actions. At UL, we offer the latest ISO 13485 quality certification to support global regulatory requirements. Our services include non-clinical testing; usability studies; EMC and performance testing; safety certification; and compliance training in order to facilitate speedy and unrestricted access to both local and international markets. We also work directly with government agencies around the globe to help inform IT policy, especially as it relates to cyber security and interoperability. UL’s global presence further enables us to offer our customers testing, regulatory and certification services in their own languages and time zones, as well as to meet regulatory requirements in multiple counties. And we provide comprehensive, customised learning management systems that can be integrated directly into their compliance and quality systems in order to demonstrate compliance to regulators. The benefits of this integrated approach are real and quantifiable, and include lower costs, reduced business risk and, ultimately, healthier patients. Speak to UL about becoming your partner in safety and quality assurance today. www.ul.co.za

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Profile for Enterprise Africa

Enterprise Africa May 2017  

May's Enterprise Africa

Enterprise Africa May 2017  

May's Enterprise Africa