hello everybody,
Meanwhile i have read a lot about the requirements regarding change control, but it is difficult to find a practical way for realising them.
According to QSIT the change control procedure or procedures must meet "pre-production design changes" and "post-production design changes".
So the first requirement means design changes during the development of a medical device, the second requirement means design changes after the development has finished and the product is launched to the market.
We established a change control procedure for post-production changes, but not for changes during the development. Management is of the opinion, during the development of a product we have to stay "flexible" without strong rules for changes... At the moment i have no idea, how i can create a simple and effective, but also correct procedure for that issue.
What are your experiences with changes during development, how do you cope with the daily problems? How do you meet this requirement of §820.20?
Thank you very much for your help and your answeres!
best regards,
Aphel
Meanwhile i have read a lot about the requirements regarding change control, but it is difficult to find a practical way for realising them.
According to QSIT the change control procedure or procedures must meet "pre-production design changes" and "post-production design changes".
So the first requirement means design changes during the development of a medical device, the second requirement means design changes after the development has finished and the product is launched to the market.
We established a change control procedure for post-production changes, but not for changes during the development. Management is of the opinion, during the development of a product we have to stay "flexible" without strong rules for changes... At the moment i have no idea, how i can create a simple and effective, but also correct procedure for that issue.
What are your experiences with changes during development, how do you cope with the daily problems? How do you meet this requirement of §820.20?
Thank you very much for your help and your answeres!
best regards,
Aphel