Regulatory Compliance, Quality and Operations

Regulatory Compliance and Quality Processes - Mazza Healthcare

Mazza Healthcare recognizes we are all in the business of saving lives and transforming healthcare through high quality care and sustainable costs. MHC is committed to helping you achieve your quality healthcare goals.

MHC brings an ongoing commitment to patient safety and wellness. This commitment manifests itself most directly in our regulatory architecture. MHC have created all systems, processes, testing, procedures, and documentation to meet your exacting standards and specifications, as well as those of all regulatory bodies, including the FDA. We are committed to pre-shipment inspection and quality testing of all components. Our quality testing will further reinforce our commitment to reliable and consistent quality, dedicated to patient safety.

Our ISO 13485 certification and Regulatory Compliance record forms the foundation of Mazza Healthcare’s commitment to consistent quality and service.

  • Our Quality Alliance Strategy provides our customers with the assurance that we are committed to the consistent transformation of knowledge and ideas into new or improved healthcare solutions.
  • MHC pursues your healthcare/quality care goals with the confidence that all quality and safety aspects are at the forefront of your products and are closely monitored through our integrated managed healthcare system.

Mazza Healthcare’s credentials:

  • ISO 13485 certification.
  • Creation of systems, processes, documentation, testing, and procedures to meet the requirements of the FDA, Customs, and other regulatory bodies.
  • Experienced QA/QC team to guide inspection and testing processes to ensure products meet all our customer’s specifications and the highest quality standards.
  • Development of product specifications, quality and inspection plans to ensure product consistency and manufacturing compliance.

Targeted metrics to ensure customer satisfaction:

  • “Continuous improvement” philosophy, periodic QMS management reviews.
  • Vendor scorecards:  track product quality and performance parameters.
  • Partners in Chasing Zero (product quality, on-time delivery and quantity reliability, order processing efficiency, complaint management process).

  Patient Safety and Wellness  

MHC’s quality certification process and procedures are designed to manage risk along with ensuring the highest level of service, quality, and patient safety.