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Like many industries, progress within the medical field depends on innovation. This innovation has produced novel ...
ISO 13485 is an International Organization for Standardization (ISO) standard originally developed in the 1990’s, ...
Farmington Hills, MI, June 17, 2016– Enterprise Services Outlook Magazine has ranked E.M.M.A. International ...
Within the United States, cigarette smoking is the leading cause of preventable death; accounting for over 480,000 ...
A need to have an effective and modern approach for a pharmaceutical Quality Management System (QMS) resulted in ...
The quality management system of a medical device manufacturer is important for several reasons, but today we are ...
FDA 21 CFR 820 details the regulatory requirements medical device companies must comply with to manufacture and ...
In 2007, several high-profile drug safety problems triggered Congress to mandate the FDA to develop an active ...
With the release of the Unique Device Identification (UDI) System Final Rule in 2013, manufacturers have been ...
In Back to Basics: Complaint Handling – Part I the basic requirements for complaint handling were discussed and we ...
In today’s fast paced society, innovation and progress are the name of the game, especially in the medical device ...
Imagine, for the last five years you have worked to design a new, low-risk medical device and you are now ready to ...
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