Quality Assurance and Control

The essence of medical device quality management systems is to provide a structured approach and strict adherence to drive product quality that meets customer requirements while delivering the necessary information for effective management.

ISO 13485 is a comprehensive standard that is particularly effective in meeting the quality management system requirements of the medical device industry. By adopting ISO 13485, manufacturers establish a strong foundation for maintaining regulatory compliance and demonstrating a commitment to the safety and efficacy of medical devices.

ISO 13485 is globally recognized as the best model for demonstrating compliance with regulations and laws governing the medical device industry. It is essential for compliance with regulations around the world, including the U.S. FDA, EU MDR, EU IVDR, MDSAP, TGA, Health Canada, and other regulatory bodies. Its implementation is not only mandatory but also beneficial to the medical device organization’s regulatory compliance efforts.

Quality Management System (QMS)

Excellence is achieved through a well-executed quality system, which brings business processes under control and provides essential information for continuous improvement.

  • Adapt or build a new quality management system
  • DHF, RMF, Technical File Remediation
  • Implementation or upgrade of systems to comply with ISO 13485:2016, FDA 21 CFR 820, and EU MDR.
  • Outline how to review and improve processes across your organization
  • Compliance to ISO 14971, ISO 62304, IEC 60601 4th Edition
  • Assist and participate in U.S. FDA/NB inspection/audit

Design Quality Services

Our design quality engineers collaborate with new product development teams to ensure the latest quality management system is implemented throughout the development process.

  • Identification of critical characteristics in the design
  • Train and provide clarification on QMS to the engineering and manufacturing team
  • Responsibility in completing a risk assessment and FMEA
  • Development of Measurement System Analysis (MSA) for the best inspection methodology
  • Traceability Matrix
  • Risk Management File (RMF)
  • Design Input/Output and Design Transfer

Supplier Quality Services

To ensure the delivery of the highest quality product, our supplier quality engineers collaborate with manufacturing facilities and suppliers.

  • Responsible for Supplier Corrective Action Reports (SCAR)
  • Improve supplier-related metrics including on-time delivery and better FPY
  • Execute processes like 8D and root cause analysis
  • Ensure proper documentation including pFMEA, risk analysis, and process capability
  • Perform periodic supplier audits
  • Notified Body(NB) Audits
  • Coordinate between R&D and Supplier
  • Supplier Validation Processes