North America
Recently a wide range of X-ray and computerized tomography technology were discovered to be acutely vulnerable. According to researcher Scott Erven, an unnamed organization exposed intelligence on over 68,000 systems, causing alarm. Erven noted that passwords to such...
North America
by Priya Bhutani, CEO RegDesk – Summary Technical Document (STED) is the proposed harmonized format used for regulatory submissions by the Global Harmonization Task Force (GHTF). Albeit STED is in its pilot phase, it has the potential to standardize format for...
Asia
Learn about what Global Medical Device Regulations regulatory stands for: If you are strong exporter of medical devices, you should know about global medical device regulations. Canada The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the...
North America
Any manufacturer who wants to legally market their medical device in the US intended for human use has to get FDA approval. Any class I, II, or III devices, which is not exempt and does not require premarket approval must fulfill the requirements of a 510(k) of the...
North America
By Priya Bhutani — Obtaining market approval for a medical device from the US FDA seems arduous and frightening and most manufacturers do not know where to even begin. Medical devices are subject to general controls of the Federal Food Drug & Cosmetic...
North America
By Michael Rugnetta– After a few years of ambiguity, discussion, meetings, and conferences, the FDA has finally begun to take some small but definite steps into new territories for test regulation. It was barely a year ago (November 22, 2013) that the Food and...
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