Q
Hey everyone!
First of all I wanna thank you all for a very comprehensive and helpful Forum! Looking around here have helped me a lot during the last few weeks.
I´m a newbee in the Quality area, working in a small company in Europe (4 employees) who are currently working to implement a Quality Management System and Risk Management System according to ISO 13485, ISO 14971 and IEC 62304. We have a quite suffed schedule and our investors require us to gain CE mark before the end of summer. So we need to implement and applicate a good QMS and Risk Management System fast, accurate and efficient.
In my point of view, our biggest RISK in attempt to reach our goal is the RISK MANAGEMENT of the software. Does anyone have any useful tips regarding how to implement RISK MANAGEMENT for medical software (CE CLass IIa) when it comes to issues as ACCEPTANCE LEVELS, PROBABILITY and VALIDATION and ELIMINATION of UNACCEPTABLE RISKS.
I have so far revised ISO 13485, ISO 14971, IEC 62304, TIR320412 and a draft from the european version on how to implement 14971 with respect to software application.
THANKS!
First of all I wanna thank you all for a very comprehensive and helpful Forum! Looking around here have helped me a lot during the last few weeks.
I´m a newbee in the Quality area, working in a small company in Europe (4 employees) who are currently working to implement a Quality Management System and Risk Management System according to ISO 13485, ISO 14971 and IEC 62304. We have a quite suffed schedule and our investors require us to gain CE mark before the end of summer. So we need to implement and applicate a good QMS and Risk Management System fast, accurate and efficient.
In my point of view, our biggest RISK in attempt to reach our goal is the RISK MANAGEMENT of the software. Does anyone have any useful tips regarding how to implement RISK MANAGEMENT for medical software (CE CLass IIa) when it comes to issues as ACCEPTANCE LEVELS, PROBABILITY and VALIDATION and ELIMINATION of UNACCEPTABLE RISKS.
I have so far revised ISO 13485, ISO 14971, IEC 62304, TIR320412 and a draft from the european version on how to implement 14971 with respect to software application.
THANKS!

