UL designed the UL IEC 62304 certification to provide a framework to evaluate the robustness and maturity of a medical device manufacturer’s cybersecurity controls and capabilities in product development, according to a news release.
Philips said in the release that UL performed an audit of its Philips Security Center of Excellence, which was launched in 2015 to develop cyber-resilient products and services through security-by-design, risk assessment, vulnerability and penetration assessment, specialized training and incident response. The Amsterdam-based company said the certification verified its many product security processes.
“To receive this certification from Underwriters Laboratories, a long-established global leader in standards creation and safety testing, is a strong validation of our program and an opportunity to advance healthcare and personal health product security even further,” Philips global product security & services officer Michael McNeil said in the release. “At Philips, we understand that our customers have high and growing expectations for the security of the solutions that they rely on.
“In addition, global regulatory authorities have also increased the scope and scale of product cybersecurity compliance requirements to help protect patients and consumers. We look forward to continuing to meet these critical commitments.”