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Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.
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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 incorporating human factors engineering into the design controls and risk management plan for your product. Learn how risks can be mitigated in the early stages of product development by integrating HFE into the design of your product.
Our RA Manager Song Seto guides you through the FDAs pathway to get your combination product to the US market. Learn more about the combo products pre-market submission reviews and the other mechanism devised by the FDA and things that you should include in your pre-market submission.
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 the Health Care Industry and how you can prepare your team to follow the regulation and avoid any data breaches.
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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