According to the U.S. Department of Health & Human Services OIG(office of inspector general), the Anti-Kickback Statute was originally enacted in ...

This is one of the qualitative course which i took in this semester. I would like to evaluate myself From being a naive to Industrial exposure to basi...

Labeling of medical devices is important, both to enable the manufacturers of the devices to meet the requirements for device tracking using serial nu...

Risk management is the process of combining a risk assessment with decisions on how to address that risk, and doing so in ways that consider the techn...

Hi Viraj, A good point to discuss. Here i am sharing my views after a research on the topic. According to that research there are few steps as below...

Hi Himang, Although i don't have experience but i do research and from that I know the following: There is usually a chairperson who is responsible ...

Hi Himang, Design controls are a component of a comprehensive quality system that covers the life of a device.Design control begins with development ...

Hi Lamiaa, A good topic to start a discussion. The main consequence is the failure of that product in market.Here i would like to give some examples r...