Medical Device Risk Management Is A Tool–Not A Checkbox

It’s been a while since I last blogged about Risk Management.

Risk management is critical to understand. It’s even more critical to implement an effective and holistic risk management process. Educate yourself on ISO 14971 - the consensus standard for medical device product development. There are plenty of great free articles available on this topic too.

Mike Schmidt of Strategic Device Compliance Services is a medical device risk management expert. I had a chance to hear him speak on this topic several years ago. At the time, I was of the belief that FMEA is the only risk management tool one needs in the arsenal. After listening to Mr. Schmidt and reading articles from him over the last few years, my approach on risk management has evolved.

Too many companies have risk management processes that are overly burdensome. Too many companies still rely on FMEA as their only risk management tool. Too many companies only go through the motions and treat risk management as a “checkbox” activity.  Mike’s lastest article in MD&DI provides even more insight into medical device risk management.