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Managing design projects: New Medical Device Project or Change

#1
Hello,
I have a question about managing design projects: When we start a new project for a new medical device in R&D (for one model or more models in one family of devices), we go and document all the required design phases. What to do when these first models are already in production and on the market and we would like to introduce another model in the same family or just a new accessory to existing models (this model is similar to the existing ones and will belong to the same family of devices)? Is it necessary to start a new project for this new model and go through all of the stages of the design project or can it be introduced through the process of change management?
How is it regulatory correct and how do you deal with similar challenges?

Thank you for your help and nice regards.
 

somashekar

Staff member
Super Moderator
#2
Take as a new project because the existing model will be continued as it is, and therefore its a new device, new model number or new name etc..
A lot of design information (input review output) can be already drawn from the existing device.
Map the differences or the new things and review them, ensuring that they do not alter the safe and effective use of the existing model that is used. Address any new risks. This can be demonstrated in the Risk management file effectively.
A good mapping perhaps as a chart to the similarities and differences between the existing model and this model will do a lot good in this new design file. Identify any new testing requirements and support them with valid test records.
A design change management will not support a new device. It adds to the existing device modification / improvement. Hope this is helpful.
 
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