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Pengyoux
Pengyoux
Our Services

Quality Management Systems

PengyouX provides expert support in developing and maintaining Quality Management Systems (QMS) for medical device enterprises, ensuring compliance with relevant standards and regulations. Our services are designed to help companies establish robust quality systems, manage design control, and maintain effective risk management practices. We also offer comprehensive training to prepare teams for successful audits.

Our Offerings

QMS Development and Maintenance

  • Standards Compliance: We assist in developing and maintaining Quality Management Systems that comply with key standards and regulations, including:
  • ISO 13485: Quality management systems for medical devices.
  • ISO 15189: Medical laboratories – Requirements for quality and competence.
  • FDA QSR 21 CFR Part 820: Quality System Regulation for medical devices.
  • 21 CFR Parts 210/211: Current Good Manufacturing Practice (cGMP) regulations.
  • 21 CFR Part 4: Regulation for combination products.

Design Control Documentation:

  • Planning and Development: We support the planning, development, and maintenance of design control documentation to ensure compliance with applicable standards:
  • ISO 13485:2016: Requirements for a comprehensive QMS for medical devices.
  • FDA 21 CFR 820.30: Design controls for medical devices.
  • Documentation Management: We help manage design and development activities, ensuring thorough and compliant documentation.

Software Compliance and Usability Engineering:

  • IEC 62304: Guidance on medical device software life cycle processes.
  • IEC 62366-1: Usability engineering for medical devices, focusing on the design and development to ensure user safety and effectiveness.

Risk Management:

  • Risk Management Process: We develop or upgrade risk management processes in accordance with:
  • ISO 14971:2019: Standards for the application of risk management to medical devices.
  • Risk Management File: We assist in planning, developing, and maintaining comprehensive risk management files to ensure compliance and safety.

Audit Preparation and Training:

  • Audit Readiness: We prepare teams to successfully host audits by providing training on effective techniques and ensuring key processes are in place.
  • Training Programs: We offer tailored training for companies or individuals looking to implement, upgrade, or better understand QMS processes, including:
    • Design Control
    • Risk Management
    • Regulatory Compliance
  • Continuous Improvement: We help teams apply lessons learned from audits to improve quality systems and practices.