Hello.
A former colleague has a start-up and they are looking to gain 13485 accreditation. They are in the very early stages and one question asked was whether they would be able to gain certification whilst their product is in development?
They are are looking to gain certification by late November but do not anticipate the finished product to sign-off until late December, would this be a show stopper for gaining certification?
Thanks
Depending on who your registrar is they will come out to conduct a Stage 1 audit. You want to have at a minimum a Quality manual and procedures in place for the applicable clauses of ISO13485 that you are currently practicing. If you are developing product that is expected to be completed soon then at a minimum you should have Design Control, Risk Management, Management Controls, Document Control, Change Control, Records Control, Validation, CAPA, and Training procedures and processes in place. You should also have held at least 1 Management Review and generated records. It helps to have a few CAPAs and in particular Preventive actions in place. If you are looking at launching only a month after your registrar has come in then you would likely be in the Process Validation and PQ stages which would mean you should have batch records for those runs, have inspected incoming parts, and have started to qualify suppliers. That being said you would also be expected to have procedures and processes in place for Validation, Material Controls, Equipment Controls, Manufacturing Controls, Calibration, Inspection and Acceptance Status, Non-Conforming Product and Supplier Controls. So if you are looking to get certification a month before product launch it is likely that you will (or should) have the majority of required processes and procedures in place and for many of them have generated records. Many times they will grant you certification based on the current scope of activities e.g. Design and Development and then once you have gained regulatory approval and are ready for sales and distribution they will come back and audit you on the remainder of activities.
I would be happen to discuss in more detail if you like as I provide QMS implementation consulting services for medical device manufacturers. Hope this helps!
-Laurie
