Information for Safety in Risk Management

One common problem encountered by device manufacturers is an assertion that the content deviations in EN ISO 14971:2012 says that Information for Safety does not reduce risk.

There are two simple refutations of this misunderstanding. A content deviation requires the cumulative application of all risk reduction measures including information for safety.

The content deviation usually cited deals with disclosure of residual risk and does not make any statement about information.

There is a new paper in the Risk Management for Medical Devices aisle that explains why the common assertion is not valid.