Phillips-Medisize > CDMO Services > Quality and Execution

Quality and Execution

Quality is the Cornerstone of Everything We Do

Product quality and flawless execution are paramount to successfully delivering products that realize exceptional outcomes. Implementing stringent processes and a robust quality management system is only half the battle. You need a culture where commitment to adherence and operational excellence lie at the foundation of every step, with team members who take a proactive approach to mitigating risks before they become problems.

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Program Management

Adhering to Six Sigma quality efforts corporate-wide, Phillips-Medisize’s project teams prepare to meet your expectations for quality, cost, delivery, and overall service.

Our program management ensures your product is on the market quickly, efficiently, and profitably through:

  • Robust program management processes designed to control the most complex, multi-site programs from design and development through production
  • Seamless flow-through from concept to production
  • Single point of escalation and accountability means lower costs and faster production times
  • Coordination and support of programs that may involve multiple tools, technologies, and facilities
  • Efficient internal and external communication with the highest level of confidentiality
  • Global, customer-oriented culture
  • Cross-functional teams including customers, designers, engineers, manufacturing, and suppliers
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Quality Management

Our robust quality management system ensures we meet regulatory and compliance requirements across the organization and across the globe.

Our commitment to quality and service helps us provide high levels of efficiency and effectiveness in our work at every stage — from design and development to manufacturing and post launch.

  • Standardized global quality system processes, tools, and software platform
  • Proactive approach to risk management
  • Stringent processes and commitment to quality culture
  • Best-in-class quality controls embedded into product designs from the start
  • Regulatory and compliance across all sites to comply with applicable legal, industry and country-specific standards
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We're Committed to Compliance

View our certificates, regulations, and standards.

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We're Committed to Compliance

  • ISO 13485 Quality Management Systems for Medical Devices
  • FDA 21 CFR 820 Quality System Regulation Medical Device Good Manufacturing Practices
  • FDA 21 CFR 210/211 Good manufacturing practice in manufacturing, processing, packing or holding of drugs; general and Good manufacturing practice for finished pharmaceuticals
  • Medical Device Directive 93/42/EEC
  • Medical Devices Regulation (Regulation [EU] 2017/745)
  • Japan Quality Management System Compliance (MHLW Ordinance No. 169)
  • National Medical Products Administration (NMPA) — Quality Management Systems
  • Canadian Medical Devices Regulations (SOR/98-282)
  • ISO9001 Quality Management Systems
  • IATF 16949: International Automotive Task Force
  • Korea MFDS Medical Device Registration

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Low-Cost Connectivity in Pharmaceutical and Drug Delivery

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