Five years ago, Delphinus announced it had received 510(k) clearance from the FDA and was able to begin marketing its whole breast […]
Posts Tagged ‘Certification’
FDA Hit by Government Shutdown
Just north of downtown Washington, DC, in suburban Maryland, lies the sprawling campus of the Food and Drug Administration (FDA), […]
In Pursuit of Quality
It is standard practice for companies to review regularly their vision and mission statements. At CapeRay we aspire to be […]
Hanging Out on Hanging Rock
CapeRay currently holds the ISO 13485:2012 certificate, an international quality assurance standard that enables the “design, development, manufacture, installation, distribution and servicing […]
Of Testing and Cartoonists
The International Electrotechnical Commission (IEC) has published standard IEC 60601-1 for medical electrical equipment that mandates general requirements for basic safety and […]
Google to the Rescue
Five years ago I wrote a blog on the origins of Google, a story about two computer science students at […]
CapeRay Awarded a US Patent
Cape Town, South Africa, 5 May 2017. Following the award of a UK Patent (GB2,509,193) in July 2015 for its […]
South Africa’s New Regulations
For the past two days the South African Medical Device Industry Association (SAMED) has been holding its annual conference in […]
The Best-Laid Schemes
In 1785 the Scottish bard Robert Burns wrote his iconic poem “To a Mouse”, which begins with the immortal words: Wee, sleekit, […]
Is the FDA Too Slow?
Any company that hopes to crack the United States medical device market, currently worth more than $100 billion per annum, […]