MrTetris
Involved In Discussions
Hi all,
I would like to understand more about requirements for Packaging specifications for sterile and non-sterile medical devices. In particular, I would like to understand if packaging specs must be part of design and development documentation, or can they be handled by the manufacturing process team? In other words: should packaging specs be part of the DHF, or can they be part of DMR only? By reading FDA regulations, it seems that they need to be part of DMR only, but... I have some spare questions:
1- I often read that "by definition, medical device consists of the device itself, packaging, labelling and IFU." Is that stated in any regulation/standard?
2- Are user needs and requirements (typically considered as part of DHF) required as an input to define packaging specifications?
3- Do packaging specs (and VnV activities) need to be part of the I/O matrix?
4- If I need to include packaging specs in the DHF - can I avoid to include there the configuration of the packaging (how devices are distributed and protected inside packaging)?
5- Do I need to include brands of packaging material in the packaging specs (and do I need therefore a Design Change project every time one of these materials - or the configuration - is changed)?
In principle, it does not seem logic to me to managing packaging changes in the DHF, through Design Change projects... but it seems that NB auditors expect that, so I am afraid that a "DHF-control system" is needed.
A lot of questions, I see... any answer (in particular if supported with references to regulations/standards) would be highly appreciated. Thank you!
I would like to understand more about requirements for Packaging specifications for sterile and non-sterile medical devices. In particular, I would like to understand if packaging specs must be part of design and development documentation, or can they be handled by the manufacturing process team? In other words: should packaging specs be part of the DHF, or can they be part of DMR only? By reading FDA regulations, it seems that they need to be part of DMR only, but... I have some spare questions:
1- I often read that "by definition, medical device consists of the device itself, packaging, labelling and IFU." Is that stated in any regulation/standard?
2- Are user needs and requirements (typically considered as part of DHF) required as an input to define packaging specifications?
3- Do packaging specs (and VnV activities) need to be part of the I/O matrix?
4- If I need to include packaging specs in the DHF - can I avoid to include there the configuration of the packaging (how devices are distributed and protected inside packaging)?
5- Do I need to include brands of packaging material in the packaging specs (and do I need therefore a Design Change project every time one of these materials - or the configuration - is changed)?
In principle, it does not seem logic to me to managing packaging changes in the DHF, through Design Change projects... but it seems that NB auditors expect that, so I am afraid that a "DHF-control system" is needed.
A lot of questions, I see... any answer (in particular if supported with references to regulations/standards) would be highly appreciated. Thank you!