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It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen ...
A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to ...
What makes teams successful, based upon a study of employees working within process improvement teams for each of ...
Coronavirus (COVID-19) has been prevalent in the United States for over 2 years, on July 6th, the Food and Drug ...
If you are a drug manufacturer in the US, an Annual Drug Product Review (ADPR) should be familiar to you. ADPRs ...
When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA ...
A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the ...
There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration ...
Many marketed products are classified as medical devices and you would not even know it. Medical devices range ...
There are many ways to sterilize medical devices before use in the industry. The common methods utilized are ...
Many companies do not understand the benefits of having a structured Quality Management System (QMS). A QMS is a ...
A Fishbone diagram is a risk management tool used to visualize cause and effect to analyze the root cause of a ...
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