Should the design transfer of a medical device take place before or after design validation ?

DanMann

Quite Involved in Discussions
They typically go hand-in-hand. Your devices for validation should be produced in production equivalent environment (i.e. on your production line), so often companies will complete design verification, produce the validation units and validate the production processes at the same or similar time, then use the results of design and process validation to confirm the effectiveness of the design transfer. The sign-off that design transfer is complete tends to happen after design validation, but some companies will complete Design Transfer before Design Validation is complete to allow stock to be built prior to release of the product (although Design Validation findings may call this stock into question).
 

Tidge

Trusted Information Resource
In my experience, design validation and design transfer processes cannot be established such that one is a gating item for the other.

There is an obligation to perform design validation on "production equivalent" products, but it would be a huge waste of time and resources to complete a full suite of process validation, supplier/inventory controls, production training that would unambiguously recognized as elements of a necessary and successful design transfer before beginning a summative user validation.

Turning this around: if design outputs are not firmly established (perhaps because user validation is still necessary to determine certain elements of the finished design), it would be premature to require that a manufacturing area construct devices using fully validated processes/equipment when the DMR is still in a state of flux.
 

kingkingwang

Starting to get Involved
They typically go hand-in-hand. Your devices for validation should be produced in production equivalent environment (i.e. on your production line), so often companies will complete design verification, produce the validation units and validate the production processes at the same or similar time, then use the results of design and process validation to confirm the effectiveness of the design transfer. The sign-off that design transfer is complete tends to happen after design validation, but some companies will complete Design Transfer before Design Validation is complete to allow stock to be built prior to release of the product (although Design Validation findings may call this stock into question).
Thank you very much.
 

kingkingwang

Starting to get Involved
In my experience, design validation and design transfer processes cannot be established such that one is a gating item for the other.

There is an obligation to perform design validation on "production equivalent" products, but it would be a huge waste of time and resources to complete a full suite of process validation, supplier/inventory controls, production training that would unambiguously recognized as elements of a necessary and successful design transfer before beginning a summative user validation.

Turning this around: if design outputs are not firmly established (perhaps because user validation is still necessary to determine certain elements of the finished design), it would be premature to require that a manufacturing area construct devices using fully validated processes/equipment when the DMR is still in a state of flux.
Thank you very much.
 
Top Bottom