Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello everyone, 

For a company that makes SaMDs, (software as a medical device), does anyone have a design change control form template? I know in the world of hardware devices, there are engineering change controls and the associated forms where you assess the impact. Does the world of software have different requirements on the change control form?   Can somebody provide some insight and/or a template they would like to point me to ?  

Thanks.

Hello,

You may want to provide more details on specific change control that you are looking for. In general, the design control depends on whether prior to release or post release in market and what is the impact to DHF. We need to have a checklist covering different aspects to design changes and come up with an impacted list of documents as well as verification / validation strategy needed.

Thanks,
Loga

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Loganathan Kumarasamy
Senior Consultant
Waukegan IL
United States
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Original Message:
Sent: 09-Feb-2019 23:49
From: Anonymous Member
Subject: Software change control

This message was posted by a user wishing to remain anonymous

Hello everyone, 

For a company that makes SaMDs, (software as a medical device), does anyone have a design change control form template? I know in the world of hardware devices, there are engineering change controls and the associated forms where you assess the impact. Does the world of software have different requirements on the change control form?   Can somebody provide some insight and/or a template they would like to point me to ?  

Thanks.