What is Medical Device Product Security?Medical device product security refers to the discipline of designing, developing, deploying, and maintaining medical devices in a way that ensures confidentiality, integrity, and availability (CIA) of device data and functionality across the product lifecycle.This includes implementing technical controls, risk management, and compliance measures to mitigate threats that could compromise patient safety or regulatory compliance.Source: FDA Postmarket Management of Cybersecurity in Medical Devices, 2016
Why Is It Critical?• Patient Safety: Exploited vulnerabilities in connected devices can directly affect diagnosis or treatment (e.g., incorrect insulin delivery or pacemaker signal manipulation).Source: FDA Cybersecurity Guidance for Premarket Submissions, 2023• Regulatory Requirements: Manufacturers must comply with cybersecurity expectations defined by the FDA, ISO 14971, IEC 62304, and other global frameworks.• Reputation & Liability: Breaches in product security can lead to recalls, regulatory penalties, and loss of trust.Source: St. Jude Medical Recall – FDA Safety Communication
What Is a Secure Medical Device?A secure medical device is one that:• Has undergone cybersecurity risk assessment as part of product design (per ISO 14971)• Follows a secure software development lifecycle (per IEC 62304)• Implements technical security controls such as authentication, encryption, and secure boot• Is monitored postmarket for vulnerabilities and can be updated or patched securelySources: NIST Cybersecurity Framework (NIST CSF), FDA Premarket Cybersecurity Guidance, 2023
Who Is Responsible?Product security is a cross-functional responsibility involving:• R&D and Software Engineers – for secure design and implementation• Quality & Regulatory Teams – for compliance with FDA, 21 CFR Part 820, and IEC standards• Security & IT – for architecture reviews, monitoring, and incident response• Clinical and Risk Teams – for evaluating potential patient harmSource: 21 CFR Part 820 – FDA Quality System Regulation
Common Cyber Threats to Medical DevicesMedical devices are often targeted due to their clinical importance and connectivity. Common threats include:• Unauthorized access to device functions• Data exfiltration or tampering (e.g., ePHI)• Exploitation of unpatched software components• Ransomware affecting hospital networks and IoMT devicesSources: HSCC Medical Device and Health IT Joint Security Plan, 2019, FDA Safety Communication: Cybersecurity Vulnerabilities in Insulin Pumps

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