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FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, ...
Ensuring you have a robust Quality Management System (QMS) is the first step in maintaining compliance with both ...
Our Sr. Quality Engineer Matt Ward explains how to build a strong Design History File for your product by ...
Our RA Manager Song Seto guides you through the FDAs pathway to get your combination product to the US market. ...
China is considered to be one of the many booming medical device markets with its continually increasing ...
EMMA’s EMEA Regional Director Joseph Yammine explains how the EU’s General Data Protection Regulation applies to ...
It seems like everyone and their dog are using products containing CBD, but are they safe, effective, and in ...
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 ...
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