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#Iso 13485 design controls iso#
Now, many well-known elements of ISO 13485 can also be found in the QSR and vice versa. It is obvious that the FDA has been strongly involved in the revision of ISO 13485:2016, as QSR and ISO 13485 have become very similar. The following part will list all the subparts and explain shortly what their most important aspect is. Each part regulates an individual aspect of the whole quality system and represents an own entity. The Quality System Regulations are structured into 14 subparts. That is how it is ensured that the law corresponds to the most current state of the art. It is important to know that title 21 is revised once a year and always published on 1 April. Thus, the QSR requires manufacturers to develop and follow procedures in order to ensure high quality for that specific device they manufacture, using appropriate details and knowledge that is current state of the art. Instead, it rather provides a framework to all manufacturers, which they must follow. This would probably also go beyond the scope of the regulation. In the 21 CFR part 820 – Quality System Regulation (QSR) the FDA provides cGMP requirements for medical devices.įor the QSR must apply to a great variety of different types of medical devices, it does not regulate in every detail how exactly a specific medical device must be produced. Within the FDA-regulated realm the quality system is (also) known as current good manufacturing practice. Such a system ensures that the products conform to applicable requirements and specifications.
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In general, as a manufacturer it is important to establish and follow a quality system.
#Iso 13485 design controls code#
For that reason, the FDA provides The Code of Federal Regulation and defines quality in section 820.3 as “the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.” This excellent version is defined by set standards. But what is quality? Put into simple words, it is the most possible excellent version of an object. In the field of medical devices, it is especially important to have a clear concept of what quality is in order to apply it to a system or as a standard on products.