ISO 14971 Class II Medical Devices - Product Realization & Risk Management

[qremsg26]

Hi,

What will be the RA process flow for the medical devices Class IIa?

I am talking about the complete life cycle of the product, and not just the design.

Thanks,

 

[Marc]

Re: ISO 14971:2009 Class II Medical Devices Process Flow

Can anyone help with this one? My Thanks in advance!

 

[qremsg26]

Re: ISO 14971:2009 Class II Medical Devices Process Flow

I need to do the risk analysis for the medical device, I would need the overview process input.

Thanks

 

[bio_subbu]

Re: ISO 14971:2009 Class II Medical Devices Process Flow

I need to do the risk analysis for the medical device, I would need the overview process input.

Thanks

Refer the existing thread "ISO 13485 Cl. 7.1 Process Flow (product realization & risk management requirements)" and you can find generic risk management flowchart in post#2

 

[Marc]

Re: ISO 14971:2009 Class II Medical Devices Process Flow

Thanks, bio_subbu. I appreciate your help here.

 

[Ajit Basrur]

Hi,

What will be the RA process flow for the medical devices Class IIa?

I am talking about the complete life cycle of the product, and not just the design.

Thanks,

Which market are you referring to ? If you are talking about Australian markets, the TGA website on Medical Devices is a good place to start.

Additionally on Risk Management, the TGA gives guidance HERE

.