How can risk management principles be applied globally?
Risk management as a concept has increased in importance over the years. We are getting very attuned to sophisticated methods of risk management. One vehicle that has driven this is the publication of ISO 14971, Application of Risk Management to Medical Devices. Most, if not all, competent authorities have recognized that document, which means we have a consistent way to think about risk. Having said that, ISO 14971 is not a cookbook. It’s a framework for considering risk management. I believe its adoption throughout the device world would make an enormous difference. Q: In the past, you have said that ISO 13485 and FDA’s Quality System Regulation are as close as they have ever been to being harmonized. What more can be done, and what does this mean for global medical device manufacturers? A: I can only give a partial answer. The rest would have to come from the CDRH Office of Compliance. We are moving close to being able to use [multipurpose] audits, especially with the advent of N33.
