Good morning,
My name is Marco, I'm not an expert in medical devices field. With the company where I work I must write a Technical dossier and a risk management following the iso 14971.
I've already read that ISO but i don't know how to set up the risk management report.
The product is already on the market as cosmetic. It has all the features to become a medical device.
I know that this product is really safe but unfortunatly the manufacturer never planned a periodic review.
I really don't know how to start with the risk analysis and management.
Does some format or MD's risk analysis example exist?
My name is Marco, I'm not an expert in medical devices field. With the company where I work I must write a Technical dossier and a risk management following the iso 14971.
I've already read that ISO but i don't know how to set up the risk management report.
The product is already on the market as cosmetic. It has all the features to become a medical device.
I know that this product is really safe but unfortunatly the manufacturer never planned a periodic review.
I really don't know how to start with the risk analysis and management.
Does some format or MD's risk analysis example exist?