ISO 13485 certification advantages when I certify a Class 2a medical device

[bwin001]

What advantages does ISO 13485 certification give me when I certify a Class 2a product?
thank you

 

[AndyN]

What advantages does ISO 13485 certification give me when I certify a Class 2a product?
thank you

Certification of a Quality Management System is different to product certification, so aren't (directly) comparable. They have 2 separate purposes. You may have to certify product, but typically QMS certification is optional.

 

[bwin001]

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.

 

[bwin001]

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.

 

[AndyN]

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.

Probably your best course of action is to obtain a copy of ISO 13485 and take a look at it. That will assist you with some basics.

 

[ScottK]

So here's a summary of the Class IIa requirements:

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

you're asking what the benefit of 13485 registration is if you chose option 1?

 

[bwin001]

I have already read about the iso 13485.
the iso 13485 one can but one does not implement or it? the quality management system is only there so that everything is carefully documented and has nothing to do with product certification?

And what are the advantages of such a complete quality system according to ISO 13485?:mg::mg:
thank you

 

[AndyN]

ISO 13485 is merely about documentation it has much to do with proper implementation and is actually applied by the entities manufacturing medical devices.

In fact, ISO 13485 isn't "merely about documentation". It requires the effective implementation (risk based) of the organization's QMS.

 

[bwin001]

Thank you very much. but something is still unclear to me, the benefits would be if I want to certify the iso 13485

 

[AndyN]

Thank you very much. but something is still unclear to me, the benefits would be if I want to certify the iso 13485

The benefits are:

1) internal - you will have a defined, documented system by which you conduct your business (with confidence) and who doesn't need that?

2) external - you signal to customers and regulatory agencies that you practice a QMS which is subject to periodic surveillance - which is the norm for medical device manufacturers these days.