Design change and Process change Class 3 medical device

[adztesla]

Hi all,

Can someone help me answer the below?

1. What is considered a design change as per ISO13485 and the FDA?
2.What is considered a process change as per ISO13485 and the FDA?

Please would you advise?

It would be great if you guys can detail me the document references if there are.

Thanks!

 

[EmiliaBedelia]

Have you read ISO 13485 and the FDA guidance on changes to PMA products? Those are the documents I would reference, you can very easily obtain these from the internet.

Practically speaking, a change could impact both the manufacturing process and design (eg, a design change to use a new coating material, which may require a process change to use a new manufacturing method; a manufacturing change to a new type of machine that necessitates drawing modifications to update the tolerances). So it is probably more useful to you to use the modification assessment framework for US and/or EU to make whatever decisions you are trying to make from this question.

 

[adztesla]

Have you read ISO 13485 and the FDA guidance on changes to PMA products? Those are the documents I would reference, you can very easily obtain these from the internet.

Practically speaking, a change could impact both the manufacturing process and design (eg, a design change to use a new coating material, which may require a process change to use a new manufacturing method; a manufacturing change to a new type of machine that necessitates drawing modifications to update the tolerances). So it is probably more useful to you to use the modification assessment framework for US and/or EU to make whatever decisions you are trying to make from this question.

Thank you. I will have a look. Thanks!