As healthcare technologies become increasingly connected, regulatory scrutiny around cybersecurity is rising. ISO/IEC 81001-5-1 is the globally emerging standard that helps medical device manufacturers embed cybersecurity into the entire development lifecycle. Our new fact sheet explains key requirements, implementation strategies, and how to achieve compliance efficiently, whether you're launching new devices or updating legacy systems. Complete the form to download your copy today.

ISO/IEC 81001-5-1 Cybersecurity for Medical Devices | Fact Sheet

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IEC 81001-5-1 Compliance for Medical Devices

Intertek offers end-to-end IEC 81001-5-1 compliance services with cybersecurity assurance for Health Software and Connected Medical Technologies to help you meet global regulatory expectations, including those from the FDA, EU MDR, and Japan’s Ministry of Health.

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