T
Hi,
I just wanted to get some feedback from any of you there familiar with the application of risk management (and more specifically risk analysis). We are a specifications developer for Class IIa medical devices. I am new to the company and have noticed that they have only previously done an analysis (FMECA) but with no real management process. Ive read in some articles that FMEA is better for Class III or safety critical parts of a device, and that different analysis methods should be used at different stages of design control. Any feedback on what Ive read or what others are doing would be muchly appreciated!
Cheers
Tan
I just wanted to get some feedback from any of you there familiar with the application of risk management (and more specifically risk analysis). We are a specifications developer for Class IIa medical devices. I am new to the company and have noticed that they have only previously done an analysis (FMECA) but with no real management process. Ive read in some articles that FMEA is better for Class III or safety critical parts of a device, and that different analysis methods should be used at different stages of design control. Any feedback on what Ive read or what others are doing would be muchly appreciated!
Cheers
Tan

