International – No Shortcuts: Building Out the Right Processes to Ensure Medical Device Safety and Security

  • Regulatory focus on medical device safety and risk management intensifying;
  • Functions such as clinical research, post-market surveillance and ISO 14971 compliance should bolster safety and risk management efforts;
  • More robust safety and risk management processes to help medical device companies pivot faster when regulators change requirements.

Ensuring safe and effective use of medical devices for patients and users is a crucial responsibility for manufacturers and developers, not only in terms of addressing regulatory requirements but also of mitigating risks to public health. In order to pass scrutiny from market regulators and demonstrate that their products do not compromise public health and trust, medical device and technology companies must tie safety and risk management processes closely to their design, development and pre- and post- commercialization efforts.

The challenges of building in safety and risk management functions across device lifecycles are significant, but manufacturers can ill afford to adopt inadequate measures if their goal is to reduce the risk of post-market problems such as field safety corrective actions (FSCAs), adverse events or device recalls. Implementing appropriate measures can also help manufacturers navigate pre-market regulatory reviews and obtain market authorizations faster. Below, we discuss considerations device companies should evaluate in order to build more robust safety and risk management processes, including clinical research and post-market surveillance capabilities, best practices for human factors engineering and usability as well as ISO 14971 compliance and related risk management approaches…