Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system. 21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1] The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Gene and Cell Therapies
EMMA International’s Body of Knowledge (BOK)
Do you enjoy all the content from EMMA International? We have good news for you! EMMA International is proud to...
New Imaging Drug for Ovarian Cancer
In November of 2021, the Food and Drug Administration (FDA) approved Cytalux. Cytalux is a new imaging drug intended to assist surgeons with the identification of ovarian cancer lesions1. This new drug was designed to assist in locating additional ovarian cancer tissues that can be…
Cartilage Regeneration Techniques
Numerous biomaterials and techniques have been developed over many decades to repair damage to the cartilage within...
World Blood Donor Day 2021
Every June 14th, the World Health Organization (WHO) hosts World Blood Donor Day to raise awareness all over the globe...
Immune Systems After the COVID-19 Pandemic
Everyone has heard that immune systems weaken when they are sheltered, but is that really the case? As we are now over...
Considerations for Biocompatibility Evaluation
Biocompatibility is one of the most critical performance studies that manufacturers need to perform as part of their...
Protecting Public Health During COVID-19
As we face the most challenging public health crises of our lifetimes, celebrating and thanking all those who serve...
Regulating Cellular Therapy Products
Cell therapies are regulated as biologics under the Center for Biologics Evaluation and Research division of the FDA....
Blood Establishment Computer Software (BECS) – SoftBank.web
Happy National Blood Donor Month! We celebrate the first month of the year as the National Blood Donor Month, and in...
Making Blood Donation Applications Smart Using Cloud Computing and IoT
We reside in a modern world where digital health services are available and can be accessed online instantly. Despite...
Medical Device Biocompatibility
If your medical device has contact with human tissue, it is a safe bet that you will be required to conduct...
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