Author: Nikita Angane

If you are a manufacturer of a radiation-emitting medical device, then 21CFR 820 is not the only regulation that you need to comply with. Title 21 of the Code of Federal Regulations, Parts 1000 through 1050 (21 CFR 1000 –...

Quality and performance standards are revised every three to five years, or sometimes sooner, depending on the industry need. European regulations accept European specific versions of ISO standards when assessing conformance of the product and the organization’s quality management system. The...

The US Food and Drug Administration has the responsibility to ensure that medical devices being imported into the US comply with the applicable regulations. A foreign manufacturer, defined as a manufacturer located outside of the US, must comply at a...

February 3rd is celebrated as National Women Physicians Day. This day marks the birthday of Dr. Elizabeth Blackwell, the first woman to receive a medical degree in the United States in 1849. The day is celebrated in recognition of female...

Health Canada recently published SOR/2020-262 amending the Food and Drug Regulations and the Medical Devices Regulations (CMDR). The amendments under these regulations strengthen Health Canada’s ability to collect post-market safety information in support of Vanessa’s Law (Protecting Canadians from Unsafe...

January 12th is celebrated as National Pharmacist Day to recognize all the pharmacists across the nation. In addition to surgeons, nurses, and paramedics, this is another profession that contributes immensely to the health care industry. Historically, pharmacists only dispensed prescribed...

The Medical Device Single Audit Program covers the compliance requirements of the USA, Brazil, Japan, Canada, and Australia. Although this program does not cover the requirements of the EU, which is the EU MDR and IVDR, a guidance document released...