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India’s medical device market is growing exponentially. The medical device industry in India is presently valued ...
With the continued advances of Artificial Intelligence and Machine Learning (AI/ML), we are at the forefront of a ...
Are you working with a product whose fitness for use or quality deteriorates over time? Does your Quality ...
With less than a year until the end of the EU MDR transition period, it is pertinent to ensure that all devices to ...
FDA defines data integrity as the completeness, consistency, and accuracy of data. Data Integrity is not a new ...
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On May 8, 2019, FDA released draft guidance, Clinical Lactation Studies: Considerations for Study Design, building ...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 ...
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