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Post-Market Surveillance (PMS) is required for medical devices. There are two types of post-market surveillance – ...
On numerous occasions, we have seen companies’ websites and products boasting with an FDA approved stamp on it. ...
The Unique Device Identification system is used to identify the device throughout its distribution and use on the ...
With the increasing use of software in every medical device, it is very important for every manufacturer to know ...
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On May 8, 2019, FDA released draft guidance, Clinical Lactation Studies: Considerations for Study Design, building ...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 ...
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