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Difference between ISO 13485 and FDA 21 CFR 820

The slides contain a brief about the relation between the ISO 13485 and FDA 21 CFR 820 in respect to a medical device

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Difference between ISO 13485 and FDA 21 CFR 820

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  1. Difference Between FDA 21 CFR Part 820 and ISO 13485

  2. Through the span of over 20 years in regulatory affairs and quality consistency, we’ve figured out how difficult it very well may be to actualize a quality administration framework that successfully empowers effective item advancement while conforming to both residential and international quality framework requirement. However, it is important to clarify the differences and the consequences of these in the actual work field hence, let’s have a glance at their differences in Quality system regulation.

  3. What is ISO 13485? ISO 13485 determines necessities for a quality management system where an association needs to exhibit its capacity to give medical devices and related administrations that reliably meet client and relevant regulatory prerequisites. Such associations can be engaged with at least one phases of the life-cycle, including outline and advancement, generation, stockpiling and dispersion, installation, or adjusting of a medical gadget and plan and improvement or arrangement of related exercises (e.g. specialized help).

  4. What is FDA 21 CFR Part 820? FDA 21 CFR Part 820 aka the Quality system regulation highlights current good manufacturing practices (CGMP) regulations that control the techniques used in, and the provision and controls used for, the manufacture, design, labeling packaging, installation, storage as well as servicing of all finished devices manufactured for human use. These needs are meant to meet to ensure that medical devices are effective and safe.  Device manufacturers go through FDA inspections to make assure FDA 21 CFR 820 Compliance.

  5. Where do they apply? • ISO 13485 identifies as a global standard that is not mandatory in the US however mandatory in some countries. CB’s plan audits to assure conformance. • 21 CFR 820 is associated with medical device manufacturers of finished devices sold in the US, along with imported products. Some parts of the requirement might apply and this also depends on the medical device class.

  6. Differences Between ISO 13485 And 21 CFR Part 820

  7. Thank You!

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