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A root cause is a factor which caused a nonconformance and should be permanently eliminated through process ...
On May 8, 2019, FDA released draft guidance, Clinical Lactation Studies: Considerations for Study Design, building ...
Validation requirements apply to software used as components in medical devices, to software that is itself a ...
Does your Quality Management System support using a 3D printing process to manufacture a medical device or a ...
The conference and the course will focus on how FDA is adapting to the digital medical devices era and what ...
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a ...
This will be the first ever Medical Device Summit held in Michigan
Farmington Hills, MI, May 13, 2019 –E.M.M.A. ...
As part of our blog series on Artificial Intelligence and Machine Learning Medical Devices, this time we will ...
As part of our blog series on artificial intelligence and machine learning driven medical devices, we discuss ...
FDA expects every medical device manufacturer to have a robust and compliant quality system. FDA has been taking ...
Happy World Immunization Week! Lately, we’ve heard about outbreaks of diseases that we previously thought were ...
On April 2, 2019, FDA released their proposed regulatory framework for modification to Artificial Intelligence / ...
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