A well-recognized project process can allow you to exercise control over projects, especially in a multi-project environment. This is key in developing products in a short time and at a low cost while still meeting regulatory requirements.
This article covers the typical document deliverables that you will have in a medical device product development project. Bear in mind that this is merely a simplified overview to help you understand the flow of information and the logic behind the process, as well as that different companies may have different approaches and use different terminology.
Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.
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