J
Jeffers
Hello Elsmar,
I hope I am placing this in the correct location. This is a very rookie question, but I am having difficulty connecting certain dots regarding our Technical Documentation Submission. I submitted out technical documentation to my NB for review. Among other comments, I received the following non-conformity:
"Harmonized standard such as ISO 14971, ISO 10993, EN 980, BS EN 1041, BS EN 1641, ISO 7405 and those related to packaging test was not considered and there is no evidence that the requirements are met."
Our quality management system has been assesses and registered to ISO 13485:2003, and claims compliance with MDD. I never claimed compliance to the other standards, is this an acceptable answer/defense? I understand that ISO 14971 is referenced in 13485, but I did not see any references to the other standards in MDD or ISO 13485. How does one justify that they are not applicable?
Thank you in advance for any assistance anyone is able to provide, I would be happy to answer any additional questions if it will be helpful.
I hope I am placing this in the correct location. This is a very rookie question, but I am having difficulty connecting certain dots regarding our Technical Documentation Submission. I submitted out technical documentation to my NB for review. Among other comments, I received the following non-conformity:
"Harmonized standard such as ISO 14971, ISO 10993, EN 980, BS EN 1041, BS EN 1641, ISO 7405 and those related to packaging test was not considered and there is no evidence that the requirements are met."
Our quality management system has been assesses and registered to ISO 13485:2003, and claims compliance with MDD. I never claimed compliance to the other standards, is this an acceptable answer/defense? I understand that ISO 14971 is referenced in 13485, but I did not see any references to the other standards in MDD or ISO 13485. How does one justify that they are not applicable?
Thank you in advance for any assistance anyone is able to provide, I would be happy to answer any additional questions if it will be helpful.
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