According to the U.S. Department of Health & Human Services OIG(office of inspector general), the Anti-Kickback Statute was originally enacted in 1972 to protect patients and federal healthcare pr...

Hi all, In the video lecture Dr.Simon mentioned about two terms of contract,Written & Verbal agreement. He said that verbal contract can be legal but what if the due to dispute or other reason the...

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 basic knowledge holder after learning from this course...

Labeling of medical devices is important, both to enable the manufacturers of the devices to meet the requirements for device tracking using serial numbers and to enable customers in the clinical sett...

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 technical and social aspects of the risk assessment. Ri...

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, 1- Documentation Reviews 2- Information Gathering ...

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 for coordinating the preparations for the design rev...

Design transfer which is an integral process in the early life of a product, it must be well executed for complex medical devices.And as Professor mentioned if it satisfies the FDA quality rules &...

Hi Himang, Design controls are a component of a comprehensive quality system that covers the life of a device.Design control begins with development and approval of design inputs, and includes the des...

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 recently happened though they are not related to me...