This is a change request template. We designed it for medical device companies that want to document change requests using their own change control procedures. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.
This is a standard operating procedure template. We designed it for medical device companies that want to document their quality management system procedures. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.
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So, what are ‘User and Business Needs’ and why do we need them?
Medical devices, at a fundamental level, need to be safe and effective. More specifically, they need to be safe and effective when used in the context of their intended use. Regulatory markets around the world have recognized that ensuring that manufacturers consider users throughout design and development is critical to the success of a device and the safety of patients.
We take you through how to create a high quality user needs document with some examples.
Ever wondered whether it was sufficient to use ISO 14971 instead of EN ISO 14971 for the European medical device market? This gives a quick breakdown of what the difference is, and why you need the EN ISO.
This is the first part in a series which steps through how to create design and development documentation from user needs to test cases.
This part covers an introduction to the documentation hierarchy and how documents interact with each other.
