J
Hi ... Extremely new to this forum but have found it very useful from the outside looking in.
I'm a relatively new employee that works for a very small 12 person company that produces a software only medical device. We are honestly playing catch up after our last audit so being the documentation guru I've been tasked on getting us up to speed and have been recently focusing my efforts on design control procedures and deliverables.
The design method that closely fits out development teams model is called rapid prototyping which in general runs thru the following steps:
1. Define high-level user needs
2. Develop a prototype
3. Prototype acceptance testing
3. Review the prototype with the stakeholder
4. Rework it if necessary
The prototype is not discarded, but rather becomes the unit that eventually goes into production after alpha and beta testing is complete. Being a small company this methodology works well and my intent is not to change how they do it but to assure they meet the design control requirements outlined in CFR part 820.
My issue is that, since the concept and design phases are kinda meshed into one when dealing with rapid prototyping, there is no finalized user requirements for us to do a traceability matrix design verification since it is technically still in a draft mode until the prototype is actually done too. Can anyone offer any advice on how to perform design verification for such a scenario?
I'm a relatively new employee that works for a very small 12 person company that produces a software only medical device. We are honestly playing catch up after our last audit so being the documentation guru I've been tasked on getting us up to speed and have been recently focusing my efforts on design control procedures and deliverables.
The design method that closely fits out development teams model is called rapid prototyping which in general runs thru the following steps:
1. Define high-level user needs
2. Develop a prototype
3. Prototype acceptance testing
3. Review the prototype with the stakeholder
4. Rework it if necessary
The prototype is not discarded, but rather becomes the unit that eventually goes into production after alpha and beta testing is complete. Being a small company this methodology works well and my intent is not to change how they do it but to assure they meet the design control requirements outlined in CFR part 820.
My issue is that, since the concept and design phases are kinda meshed into one when dealing with rapid prototyping, there is no finalized user requirements for us to do a traceability matrix design verification since it is technically still in a draft mode until the prototype is actually done too. Can anyone offer any advice on how to perform design verification for such a scenario?