What is Risk Analysis certificate? Class III Medical Sutures

[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.


Regards,
Raghu

[Stijloor]

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.

Regards,
Raghu

I am not a medical devices expert. An (advanced) search on "Risk Analysis Certificate" in the Cove Forums revealed this. Read each of the threads/post to see if any of this would answer your concern.

Stijloor.

[Ajit Basrur]

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.

Regards,
Raghu

Hi Raghu,

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

[gholland]

Here is what we commonly refer folks to here at the Cove for 'foreign' (not US) countries:

http://www.ita.doc.gov/td/health/regulations.html

The only neighbors to Saudi that are on there are Egypt and Jordan. Neither reference a 'risk analysis certificate'. When you find out what it is, please let us know. My bet is that you are required to submit a letter on your company letterhead that says 'we have conducted a risk analysis and there is no unacceptable risk' or something similar and then have your risk analysis documentation available for review.

Good luck!

[temujin]

Hi,

the only thing I can think they mean is a Certificate of ISO 14971 Compliance made by an accredited certification body.
Some certification bodies offer this although this is not widespread.

t.