Description
Why it is useful
Design control requirements apply to all medical devices that are put on the market in the EU and most for the US market. Having a streamlined and clear design control procedure helps you implement the requirements from the QSR, MDR and ISO 13485:2016 to facilitate efficient and effective development of medical devices.
How to use it
1. You may use this procedure template in your quality management system after adapting it to your needs and removing the informative text.
2. Use the template as an inspiration while authoring your own procedure.
3. Use the template as a benchmark to check your own existing procedure.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.
All texts that are not blue are example texts that can and should be edited by you.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text must be customised to your situation.
Support
If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible
on this link when you are logged into your Medical Device HQ account.
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