IEC 81001-5-1 – Cybersecurity Consulting for Medical Device Software (SaMD)
What we offer
Clear and understandable implementation of cybersecurity standard IEC 81001-5-1
Logical connection with the Risk Management File, Design Controls and Software Architecture
Practical training and guidance on how to apply cybersecurity during:
Software Development Planning
Requirements Analysis
Software Architectural Design
Software Verification & Validation
Software Release and maintenance
Preparation of a complete Cybersecurity file
Conduction of Threat/Risk Analysis of your Medical Device Software
Who Does IEC 81001-5-1 Apply To?
Compliance with IEC 81001-5-1 applies to manufacturers and developers of medical device software and connected medical devices. This includes organisations developing standalone medical software, as well as those incorporating software into hardware devices, particularly those operating in regulated markets like the EU, the U.S., and other jurisdictions.
Cybersecurity threats targeting medical devices pose risks to patient safety, data integrity, and device functionality. Regulators such as the EU MDR, FDA, and IEC standards committees mandate cybersecurity measures to minimise these risks. Compliance with IEC 81001-5-1 ensures that medical device software meets internationally recognised security standards, safeguarding users and meeting regulatory obligations.
Compliance requirements for IEC 81001-5-1 are linked to broader regulatory frameworks, such as the implementation of EU MDR/IVDR (2021/2022), which emphasise cybersecurity as part of medical device compliance, or the FDA's cybersecurity guidance, which outlines expectations for medical devices in the U.S.
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