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