I have a couple of QMS documentation questions in a grey area and I was hoping to get some opinions on this.
A company has been developing a device over the years but without a QMS so there is no design history file or device master record to speak of. Please note this is a device startup. It went through clinical testing under an investigational authorization which does not require a QMS. Years later in 2019, they would like to start writing the DHF documents for this device and would like to integrate the DHF into the QMS. There are two questions:
1. The company would now like to make changes to the design and start working toward a commercial prototype. Does it make sense to bring the original investigational version into the QMS or writing the DHF retroactively and implement in the QMS? Or does it make sense to to start documenting the new version for the commercial type? And in parallel, keep the original clinical investigational device design history and manufacturing out of the QMS?
2. Here is a wrinkle. The company would like to eventually complete a regulatory submission but the submission will be based on clinical data collected from the clinical investigational device. In this case, presumably, the DHF should come from the original investigational device. Can this clinical data be also used to support regulatory submission of the modified device? The commercial prototype for which they would like to document in the QMS is very similar to the clinical invest. device but with some design changes.
I look forward to your insights. Thanks so much.
A company has been developing a device over the years but without a QMS so there is no design history file or device master record to speak of. Please note this is a device startup. It went through clinical testing under an investigational authorization which does not require a QMS. Years later in 2019, they would like to start writing the DHF documents for this device and would like to integrate the DHF into the QMS. There are two questions:
1. The company would now like to make changes to the design and start working toward a commercial prototype. Does it make sense to bring the original investigational version into the QMS or writing the DHF retroactively and implement in the QMS? Or does it make sense to to start documenting the new version for the commercial type? And in parallel, keep the original clinical investigational device design history and manufacturing out of the QMS?
2. Here is a wrinkle. The company would like to eventually complete a regulatory submission but the submission will be based on clinical data collected from the clinical investigational device. In this case, presumably, the DHF should come from the original investigational device. Can this clinical data be also used to support regulatory submission of the modified device? The commercial prototype for which they would like to document in the QMS is very similar to the clinical invest. device but with some design changes.
I look forward to your insights. Thanks so much.