Risk management is just plain hard — complicated, conflicted, confusing. And it’s getting harder.
ISO 14971 is being revised. The new standard adds new definitions… changes the clause numbering… introduces new requirements… changes many of the annexes and moves them to a new document.
And at the same time the EU is in transition to new regulations. There are new concepts… new risk reduction requirements… and new applications. Two areas of impact are side effects (residual risk) and benefit-risk analysis as a life-cycle requirement.
Are you prepared for these changes? Have you worked on risk analysis and evaluation with your team? Are your risk management files and plans up-to-date?