In honor of this week being National Women’s Health Week, it’s important to not only speak about the illnesses and...
Medical Devices
Woman’s Health and Infertility
In honor of this week being National Women’s Health Week, it is important to touch on the topic of infertility....
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.
Nonclinical Good Laboratory Practices
Laboratories, whether clinical or non-clinical, have to follow certain Good Laboratory Practices (GLP). Nonclinical...
Reporting Timelines for Adverse Events
When an event occurs related to a medical device there is the need to determine if it qualifies as an adverse event...
Medical Device PMA
In 1976, the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Acts established three regulatory...
Intended Use Validation
Medical Device Manufacturers in the United States have to comply with intended use validation (IUV) requirements....
Heart Health and Medical Devices
Heart health is an ongoing issue in the United States. While there are many methods to keep a heart healthy, sometimes...
Challenges of Reusable Medical Devices
As people are becoming increasingly concerned with the Earth’s future, they are looking for more sustainably designed...
Ending a Recall
All things must inevitably come to an end, including a medical device recall. Whether voluntary or FDA mandated, all...
Statistical Process Control for Medical Devices
There is an innate benefit to utilizing statistical techniques in any manufacturing process, but even more so for...
EMMA International’s Body of Knowledge (BOK)
Do you enjoy all the content from EMMA International? We have good news for you! We are proud to announce that our...
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