Risk Management is the single most important topic impacting the medical device industry today.
Standards are never sufficient to identify all the risk and handle all the risks. Why? Because there are a lot of stakeholders, and by the time the standard is announced, it’s already outdated. That’s why risk management is the glue between standards, and it is critical to ensure that risk management is an ongoing and continuous process, explains Peter Havel, Senior Vice President and Global Head of Medical & Health Services, at TÜV SÜD.
It’s not just about architecture; what are the critical systems engineering roles and responsibilities?