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 […]
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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 […]
Read moreWhat 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 […]
Read moreWhat are the Outputs of Design and Development
The ISO 13485 standard requires the medical device company to define expected outputs in the end of any development stage. Design and […]
Read moreWriting ISO 13485 Quality Manual – Need a tip?
A quality manual is a document that outlines the company’s intentions for managing processes in quality management. It may include rules for […]
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