The IEEE Medical Device Cybersecurity Certification Program evaluates the design, implementation, testing, and ongoing compliance of medical devices’ cybersecurity architecture, following the IEEE 2621 series of standards, which are recognised by the FDA and are aligned with US national cybersecurity strategies.
The program was developed by the IEEE 2621 Conformity Assessment Committee. It offers a straightforward, transparent evaluation process with clearly defined scopes and test requirements specific to medical devices meeting FDA submission criteria, including pre-assessment of the medical device by an IEEE-recognized lab, testing using IEEE 2621 Test Plan and Checklists, IEEE Certification Mark that helps manufacturers differentiate their products from competitors, certified products to be included in the IEEE Medical Device Registry, and assistance with submission to regulatory bodies.
The core principles of the IEEE 2621™ standards family and the Cybersecurity Medical Device Certification Program align with the cybersecurity guidance of the US FDA and the EU MDR. Adhering to these standards and completing the certification program could streamline review of regulatory submission of devices for sections related to cybersecurity of devices.
- Who is it for?
- Manufacturers of medical devices
- Regulatory affairs professionals
- Clinical technology and IT managers
- Healthcare technology suppliers and integrators
- Quality assurance and compliance officers
- Consultants and auditors specialised in regulatory readiness and conformity assessment
- What are the benefits?
Participating organisations benefit from pre-assessment of the medical device by IEEE-recognised laboratories, testing conducted according to the IEEE 2621 Test Plan and Checklists, and a standardised report of results. Certified products receive the IEEE Certification Mark, are listed in the IEEE Medical Device Registry, and gain support for regulatory submissions, while complying with the FDA submission requirements.
Ready to get your medical device certified?
Start the evaluation process by clicking on the link below.