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Quality and Compliance (Medical Devices) | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices
    The FDA also recognizes that proper maintenance, repair, and servicing of medical devices is critical to maintaining the safe, effective, and reliable performance of devices used in the...

How to write a good ISO 13485 Quality Policy

    https://advisera.com/13485academy/blog/2021/04/06/how-to-write-a-good-iso-13485-quality-policy/
    The Quality Policy should be a tool you can use to ensure that your QMS is consistently applied by all employees of the organization, and that you are ensuring …

Quality Policy - Terumo Medical

    https://www.terumomedical.com/about/quality-policy.html
    QUALITY POLICY. “. Terumo Medical Corporation develops, manufactures and distributes high quality medical products that are safe and effective, meet all applicable global …

Quality Policy | Pfizer

    https://www.pfizer.com/about/quality
    Quality Policy | Pfizer. Pfizer is committed to the delivery of safe and effective products to patients and consumers, a fundamental element of our Company’s Purpose and …

Setting good quality objectives for ISO 13485

    https://advisera.com/13485academy/knowledgebase/setting-good-quality-objectives-for-iso-13485/
    In clause 4.2.1, ISO 13485 lists quality objectives as being mandatory for a Quality Management System (QMS) in the medical device industry, which begs the questions: What are …

Quality Policy and Quality Objectives - Johner Institute

    https://www.johner-institute.com/articles/qm-system-iso-13485/and-more/quality-policy-objectives/
    The quality policy of this manufacturer is: We provide a comprehensive range of products and services due to which patients are impaired as little as possible by their diabetes. This …

Medtronic Medical Device Quality - A Progressive Leader

    https://www.medtronic.com/us-en/about/corporate-governance/medical-device-quality.html
    One of the six tenets of our Mission is: To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and …

Template: Quality Manual, Policy, Objectives

    https://openregulatory.com/quality-manual-policy-objectives-template-iso-13485/
    Quality Policy & Objectives Quality Policy Describe what your company is about, specifically, its mission and things which are important for it. Maybe you’re developing software …

Quality Policy - Polymed Medical Devices

    https://www.polymedicure.com/quality-policy/
    Quality Policy. Product Quick Finder. At POLYMED, we place the strictest demands on the reliability of our products and services. Quality assurance is therefore a firm component of …

Quality policy statement examples - Sitemate

    https://sitemate.com/resources/articles/quality/quality-policy-statement-examples/
    A quality policy statement is one of the tools which companies create and use both internally and externally. A quality policy statement is a short document published by the quality team …



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