M
Re: FDA QSR Inconsistency?
reminded of an old adage reading this:
Verification - Did we make the thing right?
Validation - Did we make the right thing?
Ultimately I keep thinking about design inputs, we need to remember that these are not solely customer requirements.
Would an inspector not be concerned with Design Inputs as just an entity, you as a company may well perform QFD, Kano and a myriad of other tools to determine customer needs but at the end of the day, you have a set of design inputs that need to be need to be converted to a realised and manufactured device following 21CFR820.
Whether or not you invested time to determine the market requirements is a business decision, as presumably you would want to sell the device.
The FDA will be concerned that the design effort shows that the inputs and output match, and of course that Design Controls are in place.
If the device meets FDA requirements it will get clearance, if however it does not meet a market need, clearance or not it will not sell.

reminded of an old adage reading this:
Verification - Did we make the thing right?
Validation - Did we make the right thing?
Ultimately I keep thinking about design inputs, we need to remember that these are not solely customer requirements.
Would an inspector not be concerned with Design Inputs as just an entity, you as a company may well perform QFD, Kano and a myriad of other tools to determine customer needs but at the end of the day, you have a set of design inputs that need to be need to be converted to a realised and manufactured device following 21CFR820.
Whether or not you invested time to determine the market requirements is a business decision, as presumably you would want to sell the device.
The FDA will be concerned that the design effort shows that the inputs and output match, and of course that Design Controls are in place.
If the device meets FDA requirements it will get clearance, if however it does not meet a market need, clearance or not it will not sell.
