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Expert Articles

Three-dimensional printing is revolutionizing the way medical conditions are treated. These printers are able to create customized medical devices and other medical products for patients. Moreover, this new market is open to any manufacturer, not just medical device companies. Therefore, manufacturers should understand the trends associated with this growing use of technology. Potential Uses for […]

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December 12, 2014

Core Value of the Week

“Communicate to be understood. Know your audience. Write and speak in a way that they can understand. Use the appropriate explanations for the person you are speaking to.” This core value is especially important when we deliver our trainings. It is very important that we know how many people we will be delivering our training […]

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December 12, 2014

Overview of ISO9001

ISO 9001 is one of the most well-known quality system standards. Like all official standards, it periodically goes through a review process in which it is updated. The next revision will be issued later in 2015. The document is now in the draft international standard stage, which is the fifth stage in a six-stage process.   […]

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December 5, 2014

Core Value of the Week

Hello Everyone, Happy TGIF! Here is the core value of the week: “Practice the “Human Touch.” Treat people as individuals and show them you care. Look for opportunities to acknowledge their uniqueness and their humanness (calls, cards, notes, gifts, etc).”

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To monitor public health more effectively, the United States government has issued regulations requiring organizations that manufacture and distribute devices to register with the Food and Drug Administration. As such, any corporation or individual looking to market a device in the United States should understand the regulations and processes involved in registration. Requirements for Registration […]

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November 26, 2014

This Week’s Core Value

Hello Everyone, Have a Happy Thanksgiving everyone!  Here is the core value of the week: “Create a feeling of warmth and friendliness in every client interaction. Every time you touch a client you’re on stage. This includes calls, visits, voicemail, letters, e-mails, and other communications. Make dealing with you an extraordinary and memorable experience.” This […]

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November 21, 2014

Pharmacovigilance Audits

Safety is of upmost concern to manufacturers and governing bodies worldwide. However, because the process can be complicated, European Union has issued several laws and guidelines over the past several years to address issues that occur as a result of safety monitoring. Examples of such laws include those that govern pharmacovigilance audits. Given these increased […]

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