Greetings everyone,
I recently started working for a medical device company that produces software after having worked in biopharma for the past four years in operations.
One of the projects I was assigned is to develop a risk based impact level related to customer complaints with definitions and criteria. I've reviewed our complaints handling system and it appears that while each complaint is categorized (e.g. functional defect, basic operations, user error, etc.) and investigated, risk analysis is not part of the procedure.
Is anyone able to provide guidance on where to begin? I'm having difficulty in going from concept to actual application.
Regards, Tonia
I recently started working for a medical device company that produces software after having worked in biopharma for the past four years in operations.
One of the projects I was assigned is to develop a risk based impact level related to customer complaints with definitions and criteria. I've reviewed our complaints handling system and it appears that while each complaint is categorized (e.g. functional defect, basic operations, user error, etc.) and investigated, risk analysis is not part of the procedure.
Is anyone able to provide guidance on where to begin? I'm having difficulty in going from concept to actual application.
Regards, Tonia