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bwin001
What advantages does ISO 13485 certification give me when I certify a Class 2a product?
thank you
thank you
What advantages does ISO 13485 certification give me when I certify a Class 2a product?
thank you
Thanks for the answer. but in the 93/42 is yet so that I can certify my product I must apply the conformity assessment procedure. And in these evaluation procedures, I can choose for myself whether to take the "Baumusterprüfung" or the complete quality system, or not? For what else do I need the 13485? Sorry for my questions but I am new to the area.
The manufacturer declares conformity with the provisions of the MDD and the Medical Devices Regulations 2002 and ensures that their products comply with relevant essential requirements. However, for Class IIa products, this declaration must be backed up in all cases with conformity assessment by a notified body. The manufacturer can choose the assessment from these options:
1. Examination and testing of each product or homogenous batch of products (Annex IV)
or
2. Audit of the production quality assurance system(Annex V: ) ISO 13485:2003(excluding Design)
or
3. Audit of final inspection and testing (Annex VI: ) ISO 13485:2003 (excluding Design & Manufacture)
or
4. Audit of the full quality assurance system (Annex II) ISO 13485:2003
Once the manufacturer has received certification from the notified body he may CE mark his products and place them on the market
ISO 13485 is merely about documentation it has much to do with proper implementation and is actually applied by the entities manufacturing medical devices.
Thank you very much. but something is still unclear to me, the benefits would be if I want to certify the iso 13485