Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.
The shift towards more home-based and distance-care may further change in a post-COVID environment.
Intensive chemistry requirements are creating massive data sets of chemicals, all of which need to be assessed for biological safety. This deluge of data is making equivocal results far more common than ever before. Fortunately, manufacturers can take steps to mitigate risk and support the safety of their products.
The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector.
While connected capabilities and wireless technology certainly lead to greater patient care, they also expose devices to greater cybersecurity risks.
Part III of the series on remediation looks at how companies can tie risk priorities into the remediation process.