A week ago, USA Today published an article written by Liz Szabo (seen right) with the provocative headline, “Massive marketing muscle pushes […]
Posts Tagged ‘Regulatory Affairs’
Language of Breast Density
Over the years, we have written multiple articles about breast density, including its reduction, legislation, diagnostic challenges and workflow optimization. One may reasonably ask: Why this […]
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), […]
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 […]