Hi All,
Looking at design traceability and expectations for showing traceability for all detail within the labelling and instructions for use back to the source requirements.
At the moment there is no formal document that provides, requirement by requirement, what each regulation needs for the development of the labels and IFU, or the outputs from risk.
And there is no link back from each statement in the labelling/IFU to what requirement it came from.
The final prepared documents are approved by QARA, confirming that the content meets the applicable regulatory requirements as per the regulatory strategy document and all outputs from risk.
The business maintains a single DTM for each device that provides references from the User Needs, at a basic level, to the the design inputs, outputs, verification and validation, however doesn't currently maintain the labelling and IFU requirements to any level of detail that would allow a content creator to develop them.
To me this seems like a gap, but putting the level of detail required to allow content creation of the labelling and IFU into a single high-level DTM seems somewhat overkill.
Obviously the regulatory requirements of each relevant country provide sources for the design inputs;
Is there an expectation that each individual requirement, such as the numerous GSPRs for labelling and IFU under the MDR, be explicitly mapped out as a design input if applicable?
e.g. would you have a labelling section of your DTM that has a design input of "label must show manufacturers name and address adjacent to manufacturer's symbol" and reference this back to the source requirement of the MDR and ISO 15223-1, or would you have this as a part of a separate specification document, or nothing at all?
Thanks,
TS
Looking at design traceability and expectations for showing traceability for all detail within the labelling and instructions for use back to the source requirements.
At the moment there is no formal document that provides, requirement by requirement, what each regulation needs for the development of the labels and IFU, or the outputs from risk.
And there is no link back from each statement in the labelling/IFU to what requirement it came from.
The final prepared documents are approved by QARA, confirming that the content meets the applicable regulatory requirements as per the regulatory strategy document and all outputs from risk.
The business maintains a single DTM for each device that provides references from the User Needs, at a basic level, to the the design inputs, outputs, verification and validation, however doesn't currently maintain the labelling and IFU requirements to any level of detail that would allow a content creator to develop them.
To me this seems like a gap, but putting the level of detail required to allow content creation of the labelling and IFU into a single high-level DTM seems somewhat overkill.
Obviously the regulatory requirements of each relevant country provide sources for the design inputs;
Is there an expectation that each individual requirement, such as the numerous GSPRs for labelling and IFU under the MDR, be explicitly mapped out as a design input if applicable?
e.g. would you have a labelling section of your DTM that has a design input of "label must show manufacturers name and address adjacent to manufacturer's symbol" and reference this back to the source requirement of the MDR and ISO 15223-1, or would you have this as a part of a separate specification document, or nothing at all?
Thanks,
TS