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Quality

Quality, Without Compromise

Your quality and confidentiality is our priority at Phillips-Medisize. On your behalf, we are able to adapt processes, while integrating systems and practices to provide traceability and documentation – required for compliance and regulatory approval and drug master files – to both our internal and your external requirements. 

Phillips-Medisize facilities are registered with the FDA for cGMP 21CFR Part 210 and Part 211 drug handling, as well as, FDA medical device manufacturing. With full quality management processes from supplier controls through finished product complaint handling, Phillips-Medisize features a quality system, which is adaptable to global requirements and provides flexibility to customers. Along with the highest quality standards, Phillips-Medisize also offers a full range of services available to you, including product packaging and contract sterilization of finished devices built to your specifications and labeling. 

As your supply-chain partner, you receive service that focuses on continuous improvements and quality assurance as demonstrated by our site and system Quality Certifications. You can expect superior quality control and process improvements from Phillips-Medisize. The high standards of service you receive from us will result in high-quality components and assemblies, on-time delivery, and the competitive pricing your program requires.

Creativity, quality and experience are yours with Phillips-Medisize – a technology-driven, global company that provides full manufacturing services from concept through commercialization

Supplier Manual

Phillips-Medisize's purchasing department has established and will adhere to procedures for the procurement of materials and services and strives to provide its customers with quality and service second to none through continuous improvement.  
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Quality Brochure

Phillips-Medisize has one of the industry's most robust quality systems in design, development and manufacturing and our facilities adhere to the most rigorous quality standards.
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If you would like copies of our facility certifications or registrations, or have other Quality related requests, please email Quality_Requests@phillipsmedisize.com.

At your service, our state-of-the-art facilities adhere to the following, rigorous quality standards:

  • ISO 9001:2008, ISO 14001, and ISO 13485
  • Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs) for 21CFR Part 210 and Part 211 Drug Packaging Requirements and FDA 21CFR Part 820 Quality System Regulations
  • Ability to provide a full range of Phase I through Phase IV Product Development Capabilities, including design verification and clinical builds
  • MHRA product certification
  • MHLW device compliant
  • CE marking
  • RoHS-compliant manufacturing process
  • UL CSA TUV certifications
  • Certified class 7 (10,000) and 8 (100,000) clean rooms
  • Support of class I, II, and III devices

A Note on Confidentiality: Your Technical information is Safe With Us 

Steps we’ve taken to protect your data include:

  • In-house tooling and design areas
  • Secure shielded areas on the manufacturing floor
  • Dedicated team members, including program managers
  • Product traceability
  • Secure data transfer and data storage
Quality manufacturing, without compromise is what you can expect

 

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