Applus+ Laboratories authorized by IEEE SA for cybersecurity testing on medical devices under IEEE 2621 Standard

The IEEE 2621 standards address the cybersecurity of medical devices, initially targeting connected diabetes-related devices but designed to be extensible to all medical device categories. This comprehensive standard addresses the growing need for robust cybersecurity measures in the medical device industry, ensuring patient safety and data protection in an increasingly connected healthcare environment. 

What This Means for Medical Device Manufacturers 

Being an IEEE SA Authorized Test Lab means Applus+ Laboratories can conduct rigorous testing required as part of the certification process to obtain the IEEE certification mark. This certification not only demonstrates compliance with cybersecurity best practices but also supports manufacturers in meeting regulatory requirements such as FDA approval. 

The testing scope under IEEE 2621 includes vulnerability assessments, penetration testing, risk analysis, and verification of cybersecurity controls. These tests are critical to ensure that medical devices can withstand cyber threats while maintaining essential performance and safety. 

Beyond Cybersecurity: Comprehensive Medical Device Testing 

While the IEEE 2621 accreditation highlights Applus+ Laboratories’ expertise in cybersecurity testing, our capabilities extend far beyond. Applus+ Laboratories offers a full suite of testing services for medical devices, including biomechanical, chemical, electrical safety, essential performance, and medical packaging testing. This integrated approach provides manufacturers with a one-stop solution for comprehensive device evaluation. 

About IEEE 2621 Series 

The IEEE 2621 series is based on internationally recognized standards and best practices for medical device cybersecurity, including the Common Criteria framework, an area where Applus+ Laboratories has extensive expertise. It was developed to address the increasing vulnerabilities in connected medical devices. For more information, visit the IEEE SA Medical Devices Cybersecurity page. 

Applus+ Laboratories: Leading the Way in Medical Device Testing and Certification 

With this new accreditation, Applus+ Laboratories reinforces its commitment to supporting medical device manufacturers worldwide in delivering safe, secure, and reliable products. As the first global testing and certification company to earn this recognition, Applus+ Laboratories is uniquely positioned to help clients navigate the evolving landscape of medical device cybersecurity and regulatory compliance.