1. Has there been a noticeable improvement with the implementation of 13485:2016 with the risk-based thinking approach?
Since we are not a consulting company, unfortunately, we really do not have feedback from the field about this matter. But, when we discuss with the client that has both our toolkit, it is noted that the risk-based approach helped them in making individual decisions. For example, when defining critical suppliers and making a decision with which to establish a quality agreement and with which not; then when determining when to go to the audit of a critical supplier - whether once a year or less often or more often; then, which software needs to be validated etc.
More information about the risk-based approach you can find in the following article: