Medical Device Risk Management Is An Enterprise-Wide Effort

I just read a blog post from AssurX “Risk Management Matures Beyond The Spreadsheet”. Great post–you should read it if you are developing and/or manufacturing a medical device. Here is an excerpt:

In conclusion, managing risk across the corporation means something different to each department yet it requires the entire organization to work together. It involves documenting and sharing risk data across the enterprise, managing workflows and tasks, while handling escalation and reporting. Yes, risk management has matured beyond the spreadsheet.

I definitely agree. I’ve written a few blog posts over the years on risk management:

• Risk Management Thoughts
• Risk Management Process
• Risk Management - A Lifecycle & Concurrent Engineering Process
• Medical Device Risk Management Is A Tool–Not A Checkbox

What surprised me ten years ago about medical device risk management still surprises me today. Very few companies consider risk management as an enterprise-wide effort. Many companies pay lip-service to this but fail to practice it. I’m also shocked by how many companies think that:

Failure Modes Effects Analysis (FMEA) = Risk Management

It doesn’t.