My company is in a pre-production design phase for a medical device that has already achieved CE Mark and had one successful clinical trial, with a larger one on the horizon.
During the CE Mark audit by a major NB, the auditor insisted that our Technical File and Essential Requirement checklist only reference the latest harmonized version of a standard, whether or not that was the one we actually owned or had used. So we revised the documents using the EN version of many standards in which we actually had or used the IEC or ISO version. I still feel uncomfortable having done that, but it was what the NB wanted, so we went along and were approved.
Scott
During the CE Mark audit by a major NB, the auditor insisted that our Technical File and Essential Requirement checklist only reference the latest harmonized version of a standard, whether or not that was the one we actually owned or had used. So we revised the documents using the EN version of many standards in which we actually had or used the IEC or ISO version. I still feel uncomfortable having done that, but it was what the NB wanted, so we went along and were approved.
- Can anyone tell me what the FDA's expectations or requirements are with regards to the standards referenced in the 510(k) and how they are identified?
- Is there any requirement that the standards that are referenced must be in stock?
- Will the FDA ask what we have done to address standards that were revised after we referenced them, with regard to impact on the design of the product or risk?
Scott