IT Evaluation & Assessment
Medical Devices IEEE 2621
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The IEEE Medical Device Cybersecurity Certification Program is maintained by the IEEE 2621 Conformity Assessment Committee (CAC), an organization composed of manufacturers, clinicians, FDA, test laboratories, cybersecurity solution providers, and industry associations from around the world.
The IEEE 2621 series of standards currently covers certification for wireless diabetes devices including:
- blood glucose monitors (BGM),
- continuous glucose monitors (CGM),
- insulin pumps, smart insulin pens, and
- automated insulin dosing systems (AID)
Authoritative websites:
What atsec offers:
atsec has IEEE authorized laboratories in Sweden, the US, and Germany, each able to provide medical device evaluation at the Basic-Enhanced Assurance Package and Moderate Assurance Package levels.
For both the Basic-Enhanced Assurance Package and Moderate Assurance Package:
- The manufacturer submits representative product samples to an authorized test laboratory.
- The manufacturer applies for certification to the Certification Body (CB).
- The authorized laboratory conducts security requirement analysis as well as vulnerability and penetration testing.
- The authorized laboratory sends the Evaluation Technical Report (ETR) to the CB.
- The CB reviews all submitted reports and makes decision on certification.
Why our services are important to you:
atsec’s IEEE 2621 portfolio encompasses the entirety of the IEEE certification process. We provide the following services:
- Performing a readiness assessment to estimate the level of effort required to successfully comply with IEEE 2621
- Developing a Security Target
- Conducting product evaluation, including security requirement analysis, and vulnerability and penetration testing
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Common Criteria Evaluation
The Common Criteria (CC), also known as ISO 15408, is an internationally recognized standard used to specify and assess the security of IT products.
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FIPS 140-3 specifies requirements related to securely designing and implementing cryptographic modules, and compliance is increasingly mandatory worldwide.
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Testing that cryptographic algorithms are implemented correctly is a prerequisite for FIPS 140-3 cryptographic module testing and NIAP Common Criteria evaluations.
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