![\"\"](\"https:\/\/www.thebusinessdesk.com\/_files\/images\/nov_26\/SleepCogni-compliance-completed-2-300x295.jpg\")
<\/p>\nSleepCogni, a Sheffield-based health-tech company behind the handheld Active-Feedback\u2122 device for sleep improvement, has confirmed it has completed all CE and FCC compliance testing for its device.<\/p>\n
This unlocks market access across the UK, Europe and the United States.<\/p>\n
Compliance means the device meets international requirements for safety, performance, and environmental protection.<\/p>\n
It moves the company from development to commercial readiness as it prepares to manufacture and supply its device to NHS and consumer markets.<\/p>\n
Independent testing was conducted by Element Materials Technology, a testing, certification and inspection provider, with assessments carried out at its facilities in Hull and Skelmersdale.<\/p>\n
Paul Ironmonger, CTO at SleepCogni, said: \u201cElement is a globally recognised leader in regulatory testing, and the process was exceptionally thorough.<\/p>\n
“Our initial pre-compliance work began in 2024, and this year\u2019s six-month programme covered every aspect of safety, electromagnetic compatibility, radio performance, and cyber security.<\/p>\n
“I\u2019m incredibly proud of our engineering and regulatory teams, achieving CE and FCC compliance first time demonstrates not only the robustness of our design but also our commitment to user safety and quality at every stage.\u201d<\/p>\n
Mark Cole, divisional director at Element, said: “We\u2019re extremely proud to work with leading advanced hardware and software technology companies like SleepCogni.<\/p>\n
“Through our partnership-based approach, we were able to support SleepCogni through their entire compliance journey.”<\/p>\n
With testing complete, SleepCogni has issued its Declaration of Conformity and the device carries the CE and UKCA marks for the UK and Europe, alongside FCC authorisation for the United States.<\/p>\n
<\/p>\n
Obtaining both CE and FCC approvals represents a key enabler for SleepCogni\u2019s next stage of growth.<\/p>\n
The certifications unlock two of the world\u2019s largest markets and signal to consumers, healthcare partners, and investors that the company\u2019s device has met stringent regulatory and safety standards.<\/p>\n
Joseph Hawkins, COO at SleepCogni, added: \u201cWorking with Element\u2019s expert teams has been invaluable. Successfully completing this process is testament to the dedication and expertise of our engineers and partners.<\/p>\n
“It\u2019s a major step forward as we prepare to deliver SleepCogni\u2019s Active-Feedback\u2122 technology to both NHS and consumer markets globally.\u201d<\/p>\n
SleepCogni’s device electronics were designed and built by Tioga, a Derby-based contract electronics manufacturer and SleepCogni’s manufacturing partner for over 10 years.<\/p>\n
With testing complete, devices are production-ready, and Tioga has the capacity to scale manufacturing to thousands of units as demand grows.<\/p>\n
Andy Grimmett, CEO of Tioga, said: “We’ve worked alongside SleepCogni for over 10 years, designing and building the high-end, technical electronics behind every device.<\/p>\n
“As a tier-one contract electronics manufacturer, we backed SleepCogni because of the strength of its engineering and its ambition to tackle poor sleep.<\/p>\n
“We\u2019re also really happy to support a UK-based company with its pioneering innovation. With production-ready devices now built and testing complete, we’re ready to scale manufacturing to support SleepCogni’s growth across the UK, Europe and the US.”<\/p>\n","protected":false},"excerpt":{"rendered":"
Compliance testing clears firm’s product for UK mass manufacturing and sale in Britain, Europe and USA<\/p>\n","protected":false},"author":238857,"featured_media":2162778,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53262],"coauthors":[62387],"class_list":["post-2162777","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-news","tag-featured-story","tag-south-yorkshire"],"yoast_head":"\n