Posts Tagged ‘Regulatory Affairs’

Don’t Lose the 3

Posted on: November 30th, 2018 by admin

Six years ago, the CEO of French manufacturer Poly Implant Prosthese, Jean-Claude Mas, was convicted and sent to jail for using non-medical […]

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 […]

Approval of “Living Drug” to Treat Cancer

Posted on: September 1st, 2017 by admin 4 Comments

In 2012 six-year-old Emily Whitehead was diagnosed with acute lymphoblastic leukaemia and, since she did not respond to standard treatment, was near […]

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 […]

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, […]

Reducing Hair Loss During Chemotherapy

Posted on: December 11th, 2015 by admin

A distressing side effect for women undergoing chemotherapy to treat breast cancer is alopecia – hair loss in which the […]

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, […]

Regulation of Medical Devices in South Africa

Posted on: August 14th, 2015 by admin

A month ago today on 14 July 2015, the Government Gazette of the Republic of South Africa published an important document entitled […]

Gene Testing Called into Question

Posted on: May 29th, 2015 by admin

Recent advances in gene sequencing technology have led to multi-gene testing – also known as “panel testing” – as a […]