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The voluntary eSTAR (electronic Submission Template And Resource) is a fillable portable document format (PDF) ...
Medical device reporting (MDR) is one of the post market surveillance tools used by the FDA to monitor medical ...
With the growth of computational capabilities, artificial intelligence (AI) and machine learning (ML) have become ...
In 1906 the Pure Food and Drug Act (Dr. Wiley’s Law) was passed by the Congress and signed by President Theodore ...
The international Banff classification is commonly used by physicians to analyze biopsies of the transplanted ...
Under FDA compliance, to bring a medical device to market, there are a multitude of regulations that need to be ...
Pharmaceutical and medical device industries face numerous challenges when it comes to marketing their products. ...
Since the introduction of the term by Seth Frank back in 2000 [1], the idea of digital health has revolutionized ...
Under FDA regulations device labelers must generate a unique device identifier (UDI) for each of their products ...
Classification of certain medical devices may be predisposed to ambiguities related to which classification type ...
Complaint management systems are a necessary part of a Quality Management System. Complaint management is defined ...
The FDA divides Life science products up into different categories with their associated centers. These centers, ...
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