My company has been asked to provide training for a medical device company on risk analysis (or risk management) and FMEA. We have on staff a medical device expert who knows risk analysis inside and out, and I have been asked to team with her and focus on the FMEA training. My background in FMEA comes from years in automotive and aerospace companies. Of course, we'll be getting together to prepare for this, but I'd like some help from all of you cove-dwelling brainiacs to get me up to speed on the finer points of applying this to a medical device company.
In the reading that I've done recently, my impression is that FMEA and risk analysis are very similar. My questions are these:
In the reading that I've done recently, my impression is that FMEA and risk analysis are very similar. My questions are these:
- What does risk analysis (or risk management) require over and above FMEA?
- Are there things in FMEA that are not normally part of risk analysis?
- Is FMEA commonly used in the medical device industry?