Is ISO 14971 certification required for IEC 62304?

[Marcelo]

Peter, you comments are totally right, and i thank you for developing the needs related to outsourcing.

In fact, whan i said ""make me a software in compliance with IEC 62304"", i was thinking about all you said, but didn´t mentioned it.

The real problem with this approach, as you said, is that it requires that the manufacturer have a excellent control of requirements for providers of service, which sadly is not always what happens.

In my point of view, the manufacturer would need to treat the provider the same way a certification body, for example, treats the manufacturer it oversees: regular auditing, compliance auditing, problem reporting, and also, as you said, there´s hava to be a strong interaction between the manufacturer and the provider regarding the design and risk management of the final product. This demands a detailed approach and process which a lot of manufacturers are not accostumed to (due to financial problems, lack of resources, lack of knowledge, etc). It may also be that this would end up costing more to the manufacturer than if he himself does it.

Anyway, it CAN be done, but only, as you say, if it´s done right from the beginning.

 

[icare2much]

Peter - very well put. I understand the complexity of the problem - the manufacturer cannot just throw the problem over the wall and expect that the subcontractor could do it all.

What I'm saying here is that it is better to formalise who does what in an agreement rather than leave it to assumptions.

Yes! Absolutely! For example - from a risk perspective - the manufacturer has inputs for risks such as complaint files - the subcontractor would have none of that. The subcontractor would be reliant on the manufacturer for early risk assessments - but then later as the design is realized the subcontractor would have to feed back any detailed risks discovered during an FMEA or the like. I see it as a very interactive process with IEC 62304 providing the "overall" framework.

A very challenging agreement is needed! (wish I had one!)