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Regulatory Compliance

SRC is an ISO 13485:2016 certified manufacturer compliant to the requirements of the Food and Drug Administration (FDA) for both Medical Devices and Pharmaceuticals. Additionally, our company is certified to the requirements of European regulations for CE (European Conformity) Marking.

Regulatory Compliance

  • Registered with the FDA as a Contract Manufacturer
    Registration #1218347
  • Compliant to 21 CFR Part 820 Quality System Regulation
  • Certified to EN ISO 13485:2016 Quality System
    Certificate Number FM 82720
  • CE certified for metrology—manufacturing of reusable, graduated, vaginal cream applicators.
    Certificate number CE 80534
  • Product inspections based on ANSI/ASQC Z1.4:2003 sampling
  • Support to 21 CFR Part 210/211 with our Pharmaceutical customers
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