Posts Tagged ‘Certification’

QT Ultrasound Launches Imaging Centres

Posted on: January 18th, 2019 by admin 2 Comments

Five years ago, Delphinus announced it had received 510(k) clearance from the FDA and was able to begin marketing its whole breast […]

FDA Hit by Government Shutdown

Posted on: January 4th, 2019 by admin 1 Comment

Just north of downtown Washington, DC, in suburban Maryland, lies the sprawling campus of the Food and Drug Administration (FDA), […]

In Pursuit of Quality

Posted on: June 22nd, 2018 by admin 7 Comments

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

Posted on: May 4th, 2018 by admin 5 Comments

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

Posted on: August 4th, 2017 by admin 4 Comments

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

Posted on: May 19th, 2017 by admin 4 Comments

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

Posted on: May 5th, 2017 by admin 9 Comments

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

Posted on: August 26th, 2016 by admin 2 Comments

For the past two days the South African Medical Device Industry Association (SAMED) has been holding its annual conference in […]

The Best-Laid Schemes

Posted on: April 15th, 2016 by admin 3 Comments

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?

Posted on: August 21st, 2015 by admin

Any company that hopes to crack the United States medical device market, currently worth more than $100 billion per annum, […]