C iTero Element product security whitepaper
This whitepaper applies to the iTero Element Family of products. Depending on the version of the product you
have procured, there may be differences in the features of the product. In addition, as this whitepaper was created
at a point-in-time, changes may have occurred in Align Technology’s product security practices to address
evolution and maturation in the product security ecosystem.
We understand the life sciences and healthcare industry and are addressing security across
the organization.
The threat of cyber-attacks to life sciences and healthcare products is
constantly evolving. With this in mind, we proactively established a product
security program that is focused on minimizing the security risk associated
with our products, enabling us to be vigilant when facing emerging threats
and to continuously improve our products.
We recognized the importance of incorporating security and privacy
considerations by design and throughout our product lifecycle. To
accomplish this, we established a cross-functional product security team,
including representatives from engineering/software development, security, legal/privacy, information technology,
and quality.
We identify security risks using robust risk management processes.
Align Technology is committed to addressing and minimizing security and privacy risks in the products that we
design, develop, and maintain. We conduct in-depth assessments of our products so that we can implement
appropriate risk mitigation measures at the outset of product development. Based on the risk level of the product,
as well as the functionality of the product, the below methodology is applied.
Product Security Risk Management Program:
Align Technology conducted the program on the iTero Element
Family of products. The methodology included planning and
information gathering, scoping product ecosystem,
performing a product security risk assessment, analyzing
threats and vulnerabilities, assessing applicable security
controls, and calculating the residual risk rating of any
identified gaps. Security and privacy risks and controls
considered as part of the assessment leverage industry
leading practice security risk frameworks including, but not
limited to, AAMI TIR57, NIST CSF, IEC/TR 80001-2-2, and
the FDA’s Content of Premarket Submissions for
Management of Cybersecurity in Medical Devices.
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
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