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Posted Dec 14, 2017 in

Spreading the holiday spirit in the workplace
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  • ISO 13485:2016 rewrites the standard for medical device manufacturing
  • Business continuity planning: vital to the life sciences industries
  • Quality by Design paves the way for innovation
  • Using the FDA’s data on citations to guide compliance efforts
  • Spreading the holiday spirit in the workplace
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When the FDA’s 21CFR Part 4 requirements for combination products went into effect, we needed external support to ensure our design history files were clearly established. We contracted Quality Solutions Now, Inc. who was able to quickly provide us with 4 resources that were experts in design control.
Drug/Biologics Manufacturer Quality Fellow
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