Medical Devices

Diabetes and Women’s Health

Diabetes and Women’s Health

Heart disease is the leading cause of death in the United States equally impacting all. Being Women’s Health Week, we want to highlight the impact heart disease has on the livelihood of women and what new developments there are in the life sciences innovation world that would reduce the impact it has on society.

Medical Device PMA

Medical Device PMA

In 1976, the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Acts established three regulatory...

Intended Use Validation

Intended Use Validation

Medical Device Manufacturers in the United States have to comply with intended use validation (IUV) requirements....

Ending a Recall

Ending a Recall

All things must inevitably come to an end, including a medical device recall. Whether voluntary or FDA mandated, all...

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