The cooperation of the companies will assist manufacturers in meeting FDA as well as other market regulators' requirements for cybersecurity risk management and mitigation capabilities of connected medical devices and systems.
Fremont, CA: EMERGO by UL, a global medical device and healthcare technology consultancy and proactive healthcare cybersecurity developer MedCrypt have established an alliance that offers comprehensive cybersecurity regulatory affairs, quality management, and technical solutions for medical devices manufacturers. The cooperation of the companies will assist manufacturers in meeting FDA as well as other market regulators' requirements for cybersecurity risk management and mitigation capabilities of connected medical devices and systems.
In 2018, the FDA issued pre-and post-market recommendations outlining concerns manufacturers must recognize when designing and developing medical devices to ensure cybersecurity vulnerabilities are adequately addressed. The post-market guidance outlines a risk-based process to ensure that manufacturers can respond quickly to emerging threats once a device is in use. EMERGO by UL and MedCrypt has established a new joint referral arrangement under which the two companies will refer prospective clients to one another and co-market their cybersecurity software solutions, consulting, and risk management services to ensure clients recognize and meet the FDA's requirements.
"While the healthcare industry has made significant strides when it comes to cybersecurity, the increase in targeted attacks in the last year alone shows us there is still significant work to be done to make security a top priority," stated Mike Kijewski, MedCrypt's CEO. "Healthcare companies and vendors are challenged with determining how to continue to innovate and deliver clinical therapies, but doing so while being secure. This collaboration with EMERGO by UL provides our combined networks of customers with a wider set of services that together ensure security is designed into a device throughout its entire life cycle, which is the best bet we have at moving the needle for better healthcare security."
