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Regulatory/Quality Compliance

Mazza Healthcare is ISO 13485:2016 Certified

Quality is at the heart of everything we do


Mazza Healthcare has an intense focus on patient safety and product efficacy through our integrated Quality Management System (QMS)

  • Development of systems, processes, documentation, testing, and procedures to meet the requirements of the FDA and other regulatory bodies

  • Ensure manufacturers adhere to both Mazza Healthcare’s and our customers’ quality requirements, processes, and procedures

  • Experienced QA/QC team guides inspection and testing processes

  • Relationships with key 3rd party inspection and testing companies (DDL, NAMSA, and ProQC)

  • In 2023, Mazza Healthcare shipped over 100 million pieces with a defect rate of < 0.1%

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