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nonconforming materials report

Keeping Good Quality Records

Medical Device companies, as well as those in other industries, strive to maintain good quality records.  This includes generation of quality records, as well as storage of those records.  This can be difficult to achieve; however, without a clear understanding of documentation and storage requirements or the methods to attain those requirements.  This White Paper discusses:

  • General documentation and storage requirements, as discussed within 21 CFR 820 and ISO 13485:2016
  • Basic methods to fulfill general documentation and storage requirements
  • Quality Record storage options for organizations with limited space availability
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