FREE ON-DEMAND WEBINAR

Change Management and Risk Management: How do we connect the dots and what happens if we don’t?

Change management and risk management are among the most important and most commonly discussed topics in the medical device industry today.

Yet in spite of that, or perhaps because of that, change management and risk management remain the “root cause” of the most common problems medical device companies experience, often leading to FDA 483 observations, warning letters or worse! Why?

Most medical device development is evolutionary, i.e., design and test a device, get it thru FDA, sell the device… then change the device and repeat. This doesn’t often happen in the drug world, but it happens in the medical device world all the time!

Medical device companies are “required” to have quality management systems in place with detailed policies and procedures on change management and risk management. But are these components integrated, or do they exist in isolation, and does one talk to the other?