ISO 13485: Medical Devices Quality Management System

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The Medical Device Quality Management System | BASE PLUS is a foundational product that contains core procedures for companies engaged in the design and manufacture of medical devices. Additional procedures can be easily added as needed. A perfect starter package for those who desire the minimum required content to obtain ISO 13485:2016 certification and FDA QSR compliance. ​

  • Quality Management System Manual
  • 38 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
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