PRACTICAL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS
Manufacturing medical devices is one thing. Keeping them secure from the production line to the patient is another. Medical IoT devices are a ripe target for cyber threats. With brand reputations, hospital operations, and patient safety all at stake, the time to address cybersecurity is now.
No device is hack-proof, but adopting FDA cybersecurity guidance will enable you to move to market faster, minimize risk of a breach, and establish trust in your brand. This is where Keyfactor can help.
In this industry-first white paper, our experts will walk you through what you need to know about:
As far back as 2011, researchers have publicly disclosed cybersecurity vulnerabilities in implanted pacemakers and insulin pumps.
In 2017, for the first time, the FDA recalled an implantable pacemaker due to concerns that it could be hacked – causing serious reputational damage and revenue loss.
A recent survey found 96% of providers point to manufacturers as the cause of medical device-related security issues.
In 2018, the FDA became more vigilant about cybersecurity in pre-market approvals, including updated guidelines for manufacturers.
Over the next decade, as many as 50 billion medical devices will be connected to the IoMT ecosystem. The time to address cybersecurity is now.