New Training Course on UL Medical Device Cybersecurity Standard Set for April 2018
UL’s Health Science Digital Health division will conduct a two-day training course on the company’s cybersecurity standard for medical devices in April 2018 in Denmark.
The course, hosted on April 12 and 13, 2018 by the Danish trade group Medicoindustrien, covers the UL 2900 standard supporting medical device manufacturers establishing proper cybersecurity features in their product processes and designs. In mid-2017, UL 2900 was added to the US Food and Drug Administration’s list of recognized standards used in medical device premarket reviews.
What the UL 2900 course will cover
The training course will encompass cybersecurity design considerations for device manufacturers and developers; effective processes and procedures to manage cybersecurity throughout a device’s lifecycle; and a review of UL 2900 and related standards addressing cybersecurity assurance.
The course is aimed at manufacturers planning to register network-connected devices under the FDA’s 510(k) premarket notification pathway; using the UL 2900 standard can support registrants’ cybersecurity assurance claims. This course may also benefit all connected device developers to understand a base set of cybersecurity processes, as well as design and testing requirements to support firms’ product cybersecurity robustness claims.
Medical software developers, product security and system engineers, healthcare IT professionals and hospital procurement professionals dealing with network-connected devices and accompanying cybersecurity issues will also find the course relevant.
Related medical device cybersecurity and regulatory resources:
- Cybersecurity support for network-connected software and devices
- US FDA 510(k) premarket notification consulting for medical devices
- Regulatory consulting for telehealth and mobile medical apps
- Webinar: Mapping cybersecurity standards to FDA guidance