Q
QA-RA Jones
All:
I am trying to figure out the difference between an ISO 13485 (issued by US registrar) and Full Quality Assurance System (CE) Certificate based on Annex II, Sec 3 of the MDD 93/42/EC (issued by EU Notified Body). Before I joined the company they had ISO 13485, however let it expire since they received a Full Quality Assurance System Certificate from a NB (CE approval). We are a US based company.
Does anyone see any benefit to having both of these certificates? Aren't they just proving out the same thing (getting audited 2x for the same thing by different groups)?
I would love to hear some opinions and comparison facts on this topic.
(We are a medical device design and distribution company)
Thank you for any input!
I am trying to figure out the difference between an ISO 13485 (issued by US registrar) and Full Quality Assurance System (CE) Certificate based on Annex II, Sec 3 of the MDD 93/42/EC (issued by EU Notified Body). Before I joined the company they had ISO 13485, however let it expire since they received a Full Quality Assurance System Certificate from a NB (CE approval). We are a US based company.
Does anyone see any benefit to having both of these certificates? Aren't they just proving out the same thing (getting audited 2x for the same thing by different groups)?
I would love to hear some opinions and comparison facts on this topic.
(We are a medical device design and distribution company)
Thank you for any input!
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