B
Blue_Adams
I have a few questions. please help.
1. What is the difference between ISO13485:2003 and ISO13485:2012?
2. I don't have a product to launch just yet but I would like my Quality System to be ISO 13485 certified. But will BSI/TUV do that?
3. IS it required to have an auditable Technical File for EU before I can be awarded the certification?
4. I have a pre-certification audit scheduled to get a gap analysis. Is not having a Technical File a deal breaker for ISO certification?
5. Do I need to establish a European Authorized Rep before I can be awarded certification?
6. Can the certification be Quality System specific and not product specific?
We are a medical device company with a Class II device, still in the middle of clinical trials and no commercialized product. So, technically a design/development company.
Looking for guidance from the quality/regulatory gurus out there!
Thanks
1. What is the difference between ISO13485:2003 and ISO13485:2012?
2. I don't have a product to launch just yet but I would like my Quality System to be ISO 13485 certified. But will BSI/TUV do that?
3. IS it required to have an auditable Technical File for EU before I can be awarded the certification?
4. I have a pre-certification audit scheduled to get a gap analysis. Is not having a Technical File a deal breaker for ISO certification?
5. Do I need to establish a European Authorized Rep before I can be awarded certification?
6. Can the certification be Quality System specific and not product specific?
We are a medical device company with a Class II device, still in the middle of clinical trials and no commercialized product. So, technically a design/development company.
Looking for guidance from the quality/regulatory gurus out there!
Thanks