FDA Compliance Article | Quality Digest

Inside Quality Digest Live for October 20, 2017

We cover a wide range of topics on QDL most weeks, but our latest episode, from Friday, Oct. 20, 2017, provided a steady drumbeat of technological detail. Here’s what we chatted about:

Design Validation vs. Clinical Evaluation

Are Your Medical Devices Secure?

If your hospital or clinic uses a Windows 7-based version of a Siemens PET/CT or SPECT system, it could be vulnerable to attack by a relatively low-skill hacker, according to a July 26, 2017,

FDA Seeks Public Input on Modernizing Regulatory Framework

Leveraging FDA Resources to Encourage Students to Pursue STEM Careers

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FDA's Oncology Center of Excellence recently launched its pilot Summer Scholars Program

Inside Quality Digest Live for August 11, 2017

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Credit: Georgia Tech

Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more.

Medical Device Manufacturers Warned for CAPA Noncompliance

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Having a CAPA process doesn’t necessarily mean that it is functional.

Fostering Medical Innovation

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According to one estimate, last year there were 165,000 health-related apps available for Apple or Android smartphones.

The Sugary Drink Tax

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A way for sugary-drink manufacturers to sweeten the bottom line

How Will Real-World Evidence Affect 2017 FDA Guidances?

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The`Advanced Medical Technology Association has asked the FDA to clarify how real-world examples support regulatory decision making

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