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.
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.