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Quality Assurance

 

Quality Assurance

 

Beacon produces specialized packaging within a continually evolving quality system that is compliant to both the FDA Quality System Regulation and ISO 13485. Beacon is a sustaining member of the American Society for Quality (ASQ), a founding member of the Sterilization Packaging Manufacturers Council (SPMC), and is an active participant in the SPMC technical committee and ASTM Committee F2 on Flexible Barrier Packaging as well as AAMI TC198/W607, the Packaging Working Group.

Compliance

  • FDA registered Class II device manufacturer, #2242794
  • Quality System meets requirements of Quality System Regulation, 21CFR 820
  • Quality System compliant with ISO 13485
  • Validation is done in accordance with ISO 11607-2
  • Test Methods used to evaluate materials and sterile barrier systems are validated in-house
  • Accepted Recognized Statistical techniques are used for establishing, controlling, and verifying acceptability of process and product characteristics

Click here to contact Beacon about Defining Statements, FDA Registration or other Beacon Quality System documentation.

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