Re: What is Risk Analysis certificate?
In Reply to Parent Post by raghuramas
Dear Forum Friends,
We manufacture class III sutures in Saudi. Last week I was asked by the government of our neighbour country to submit the Risk Analysis certificate for my products. I have Risk analysis report for all my products with latest updation as per ISO 14971 and I need Forum members advise on the meaning of the Risk Analysis certificate and its contents.
In fact the entire ISO 14971 standard doesnot contain a single word on "certificate"
Probably you can check with the authorities for more clarification and let us know too
Well done is better than well said - Benjamin Franklin