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Explained: Planning of product realization in ISO 13485 (Part 2)
In the ISO 13485:2016 standard is written what should be included in the planning of product realization in the chapter under this title. The previous article described some of the requirements that are stated in the subclause of standard, such as Processes that are needed for product realization, quality plan, quality objectives, etc. Here you…
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Explained: Planning of product realization in ISO 13485:2016 (part 1)
This chapter of the standards explains how one medical device company designs, develops, maintains and delivers medical device products. It covers the entire realization processes of the medical device and refers to all phases of the life-cycle of the medical device. Planning of product realization is the first sub-clause of Product Realization of ISO 13485:2016…
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What are Product Review Requirements as per ISO 13485
The purpose of the requirements review related to the product is to make sure companies keep to a high standard when it comes to the products and services they offer to customers. The customer has a request, and you as MedDev company will try to make your product include the requested specifications, don’t you? Therefore, …