IEEE 2621 Cybersecurity for Connected Medical Services

Connected medical devices are revolutionizing healthcare, but they also introduce new cybersecurity risks. The IEEE 2621 series of standards set rigorous requirements to protect patient safety and sensitive data in an increasingly digital healthcare environment. At Applus+ Laboratories, we deliver comprehensive cybersecurity testing services for medical devices under the IEEE 2621 standard and support in the certification process to obtain the IEEE mark.

Why Choose Applus+ Laboratories for IEEE 2621 Cybersecurity Testing?

Unmatched Security Evaluation Expertise

• Global Leader in Security Evaluations: Applus+ Laboratories stands out as a global leader in security evaluations, with decades of experience in cybersecurity assessments for critical sectors.
• Deep Roots in Common Criteria (CC) Certification: The IEEE 2621 standard is based on internationally recognized frameworks such as Common Criteria (CC). Applus+ Laboratories is not new to this field: according to the 2024 jtsec report, we are ranked as the second company worldwide in number of Common Criteria certifications. Our extensive track record in CC evaluations gives us a unique advantage in applying the robust methodologies required by IEEE 2621.
• Trusted, Recognized, and Independent: Our recent accreditation as an IEEE SA Authorized Test Lab builds on our established reputation and expertise, ensuring your devices are evaluated to the highest international standards.

What is IEEE 2621?

The IEEE 2621 series is an internationally recognized set of standards for the cybersecurity of connected medical devices. Initially focused on diabetes-related devices, its scope is extensible to all categories of medical equipment. The standard covers:

• Vulnerability assessments
• Penetration testing
• Risk analysis
• Verification of cybersecurity controls

Compliance with IEEE 2621 helps manufacturers demonstrate robust cybersecurity, meet FDA and other regulatory requirements, and build trust with healthcare providers and patients.

Our IEEE 2621 Cybersecurity Testing Services

• Vulnerability Assessment: Identify and mitigate potential security weaknesses.
• Penetration Testing: Simulate real-world cyberattacks to evaluate device resilience.
• Risk Analysis: Comprehensive evaluation of cybersecurity risks throughout the device lifecycle.
• Verification of Controls: Ensure all required cybersecurity measures are implemented and effective.
• Certification Support: Guidance through the certification process to obtain the IEEE mark.

Beyond Cybersecurity: Complete Medical Device Testing Solutions

A One-Stop-Shop for Medical Device Compliance

In addition to cybersecurity, we provide a full suite of services for medical device manufacturers, including:

• Biomechanical testing
• Chemical testing
• Electrical safety evaluations
• Essential performance assessments
• Medical packaging and transport simulation

This integrated approach means you can rely on a single partner for all your testing and certification needs, reducing complexity and accelerating time-to-market.

Why is IEEE 2621 Certification Important?

• Regulatory Compliance: Supports FDA and global regulatory submissions.
• Market Access: Demonstrates commitment to cybersecurity, facilitating product acceptance.
• Patient Safety: Reduces risk of cyber threats that could compromise patient health.
• Competitive Advantage: Stand out with independent, internationally recognized certification.

Partner with cybersecurity experts

With our unique combination of deep Common Criteria expertise, global leadership in security evaluations, and comprehensive testing solutions, Applus+ Laboratories is your trusted partner for IEEE 2621 compliance and beyond.

Contact us today to secure your connected medical devices and simplify your compliance journey!