The FDA regulates a wide range of manufactured goods for consumers, including food, electronics, medications,...
ISO
QMS Tips
Every organization that manufactures medical devices, pharmaceuticals, biologics, cosmetics, or other types of...
The Role of CMO’s in Life Sciences Manufacturing
Navigating ever-changing markets and supply chains has been challenging for many companies in the ongoing...
Pop Healthcare
For a long time, healthcare was in the hands of doctors. People listened only to their doctor’s advice on how...
Importance of Document Control on a Quality Management System
In highly regulated industries, document control is among the most necessary means for compliance. A document...
Differences Between ISO 13485:2016 and 21 CFR 820
Regulations ensure medical device manufacturers produce consistent safe products. A well-structured...
The Flu in 2021
With Halloween behind us, the most wonderful time of year is almost here, flu season! The COVID pandemic set a...
Devices in the Digital Age
As the digital age continues to advance at an amazing pace, healthcare and medical devices have managed to...
Global Regulators publish Good Machine Learning Practices (GMLP)
It is no secret that AI/ML medical devices are under a special spotlight by international regulators this...
FDA One Step Closer to Approving EUA for COVID Vaccine for Children Ages 5 – 11
So many parents, who have been on a continuum of anxiousness since the beginning of the pandemic, were finally...
Cosmetics vs Drugs: Registering with the FDA
Registering a cosmetic product with the FDA is simple, so simple it is not even required by the FDA. The...
GMP’s for Cosmetics
Good Manufacturing Practices, or GMP’s, are well known for people in the medical device and pharmaceutical...
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