Just north of downtown Washington, DC, in suburban Maryland, lies the sprawling campus of the Food and Drug Administration (FDA), […]
Posts Tagged ‘Regulatory Affairs’
Don’t Lose the 3
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
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
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
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
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, […]
Reducing Hair Loss During Chemotherapy
A distressing side effect for women undergoing chemotherapy to treat breast cancer is alopecia – hair loss in which the […]
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, […]
Regulation of Medical Devices in South Africa
A month ago today on 14 July 2015, the Government Gazette of the Republic of South Africa published an important document entitled […]