Exeed Regulatory Compliance
JULY 6, 2020
There is a lot of controversy over the use of face masks during the current Covid-19 pandemic. Since the onset of the COVID-19 pandemic, there has been a lot of conversation surrounding the shortages of Personal Protective Equipment (PPE). In that case, it becomes a medical device.
Exeed Regulatory Compliance
JULY 10, 2020
The medical landscape is constantly changing, particularly during the COVID-19 pandemic. We recently discussed the FDA’s policy for Face Masks during COVID-19. These devices can be used to help prevent the spread of COVID-19 and to provide varying levels of protection to the wearer.
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HIT Consultant
OCTOBER 10, 2022
One of the lessons of the COVID-19 pandemic has been that healthcare facilities need to scale up operations quickly to respond to a public health emergency and that doing so is a significant challenge. Hatem Zeine, Founder, President and CTO of Ossia. These applications are incredibly valuable as standalone benefits.
Healthcare Law Blog
APRIL 13, 2022
On March 18, 2022, AdvaMed announced updates to the Code of Ethics on Interactions with Health Care Professionals (“Code”), a voluntary code that provides medical technology companies with guidance on ethically compliant interactions and relationships with healthcare professionals. The changes will take effect on June 30, 2022.
Dot Compliance
FEBRUARY 3, 2022
Let’s look at what’s on the horizon for the medical device industry in 2022 and how manufacturers can achieve multiple goals by digitizing their quality operations. Best Practices for Medical Devices, AAMI, September 29, 2021 2 New draft guidance to support risk-based computer software assurance,ISPE Boston, November 7, 2019.
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