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Do Software Subcontractors need to be ISO13485 compliant in the EU?

#1
I work at a small software development firm. We've developed software for several medical device companies in the US. Typically our deliverables are the software as well as a the records and documents produced by our IEC 62304 compliant processes. None of our clients have asked whether we have our own QMS, although we are aware that many of our competitors have ISO 13485:2006 certified QMSs.

We're talking with a company that would like us to develop SaMD to be sold within the EU. This would be our first project that would be sold in the EU. They believe that we must be ISO 13485 compliant. Is this true?

As best I can tell, companies often prefer for their subcontractors to be ISO 13485 compliant, but it isn't required by the regulations.

We've been slowly developing our internal processes so as to be ISO 13485 compliant, but we're not quite done. Also, I believe the certification process takes about 6 months to complete. If we must be ISO 13485 compliant, then would it be okay if we began work on the project and became certified part-way through development?

Thank you in advance for everyone's help.
 
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yodon

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#2
Compliance with any standard is always "voluntary." No doubt, it's your best path forward, though. It's been my experience that if your software services provider is not 13485 (through an accredited registrar) then your registrar will want to audit them (at your cost).
 
#3
@yodon thank you for your comments. It's really good to know that a registrar could ask to audit your services provider if they are not ISO 13458 certified. Thanks again!
 
#4
@yodon since our client will need to be ISO 13485 certified anyway, do you think this approach would let us avoid the need to get ISO 13485 certified ourselves:

1. We help them set up a basic QMS that includes IEC 62304 compliant processes
2. Although our engineers work with our company, we follow the IEC 62304 processes we've given our client
3. Our client gets ISO 13485 certified

Also, we really appreciate your time/expertise. Feel free to direct message me if you'd like to establish a more formal consulting arrangement for this.
 
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