Setting the standard for healthcare cybersecurity

We help you meet FDA guidance. See how we map our offerings to the FDA premarket cybersecurity guidance (Final, September 2023).

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Quality system inclusive of Cybersecurity

FDA Guidance

Section IV.A.1

Device manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.

As part of design controls, a manufacturer must “establish and maintain procedures for validating the devices design,” which “shall include software validation and risk analysis, where appropriate.

Medcrypt solution

Medcrypt has developed a Cybersecurity-enabled Quality Fabric (CeQ) that provides an easy-to-follow template and model implementation of a Secure Product Development Framework (SPDF), enabling medical device manufacturers to demonstrate compliance with evolving security regulations as well as ultimately produce more secure devices.

Secure Product Development Framework

FDA Guidance

Section IV.A.1

An SPDF is a set of processes that help identify and reduce the number and severity of vulnerabilities in products. An SPDF encompasses all aspects of a product’s lifecycle, including design, development, release, support, and decommission. Additionally, using SPDF processes during device design may prevent the need to re-engineer the device when connectivity-based features are added after marketing and distribution, or when vulnerabilities resulting in uncontrolled risks are discovered. An SPDF can be integrated with existing processes for product and software development, risk management, and the quality system at large.

Medcrypt solution

Medcrypt has developed a Cybersecurity-enabled Quality Fabric (CeQ) that provides an easy-to-follow template and model implementation of a Secure Product Development Framework (SPDF), enabling medical device manufacturers to demonstrate compliance with evolving security regulations as well as ultimately produce more secure devices.

Demonstrate authenticity, including integrity, in device design

FDA Guidance

Section IV.B

FDA will assess the adequacy of the device’s security based on the device’s ability to provide and implement the security objectives below throughout the system architecture.

  • Security Objectives
  • Authenticity, which includes integrity
  • Authorization
  • Availability
  • Confidentiality
  • Secure and timely updatability and patchability.

Medcrypt solution

Medcrypt Guardian provides cryptographic protection (confidentiality, integrity, authenticity) for all data types and uses, including but not limited, to code signing.

Device designed with failure mode for system consideration

FDA Guidance

Section IV.B

Because exploitation of known vulnerabilities or weak Cybersecurity controls should be considered reasonably foreseeable failure modes for systems, these factors should be addressed in the device design.

As Cybersecurity is part of device safety and effectiveness, Cybersecurity controls should take into consideration the intended and actual use environment.

Medcrypt solution

Using Medcrypt Guardian, device configurations can be signed, and verified on application start. Should this configuration be changed, a desired failure mode (error message, warning, alert, etc.) can be specified by the device manufacturer.

Transparency

FDA Guidance

Section IV.C

A lack of Cybersecurity information, such as information necessary to integrate the device into the use environment, as well as information needed by users to maintain the medical device system’s Cybersecurity over the device lifecycle, has the potential to affect the safety and effectiveness of a device.

  • A failure to disclose all of the communication interfaces or third-party software could fail to convey potential sources of risks;
  • Insufficient information pertaining to whether a device has known but not disclosed Cybersecurity vulnerabilities or risks may be relevant to determining whether a device’s safety or effectiveness could be degraded; and/or
  • Labeling that does not include sufficient information to explain how to securely configure or update the device may limit the ability of end users to appropriately manage and protect the medical device system.

Medcrypt solution

Helm, Medcrypt's vulnerability management solution, enables management of a system's software bill of materials, including determining when vulnerabilities are relevant.

Medcrypt has developed a Cybersecurity-enabled Quality Fabric (CeQ) that provides an easy-to-follow template and model implementation of a Secure Product Development Framework (SPDF), enabling medical device manufacturers to demonstrate compliance with evolving security regulations as well as ultimately produce safer devices.                                  
Medcrypt solutions are accompanied by documentation to support FDA documentation and QMS requirements.

Actual Use Environment

FDA Guidance

Section IV.D

Device Cybersecurity design and documentation are expected to scale with the Cybersecurity risk of that device. Manufacturers should take into account the larger system in which the device maybe used.

Medcrypt solution

Helm, Medcrypt's vulnerability management solution, enables management of a system's software bill of materials, including determining when vulnerabilities are relevant.

Medcrypt has developed a Cybersecurity-enabled Quality Fabric (CeQ) that provides an easy-to-follow template and model implementation of a Secure Product Development Framework (SPDF), enabling medical device manufacturers to demonstrate compliance with evolving security regulations as well as ultimately produce safer devices.              

Medcrypt solutions are accompanied by documentation to support FDA documentation and QMS requirements.

Security risk management

FDA Guidance

Section V.A

"FDA recommends that security risk management processes, as detailed in the QS regulation, be established or incorporated...regulation which may be relevant in this context include, but are not limited to design controls (21 CFR 820.30), validation of production processes (21 CFR 330 820.70), and corrective and preventive actions (21 CFR 820.100) to ensure both safety and security risks are adequately addressed.”

“FDA recommends that device manufacturers conduct both a safety risk assessment and a separate, accompanying security risk assessment to ensure a more comprehensive identification and management of patient safety risks.”

Medcrypt solution

Helm, Medcrypt's vulnerability management solution, enables management of a system's software bill of materials, including determining when vulnerabilities are relevant.

Medcrypt has developed a Cybersecurity-enabled Quality Fabric (CeQ) that provides an easy-to-follow template and model implementation of a Secure Product Development Framework (SPDF), enabling medical device manufacturers to demonstrate compliance with evolving security regulations as well as ultimately produce safer devices.                                  
Medcrypt solutions are accompanied by documentation to support FDA documentation and QMS requirements.

Threat Modeling

FDA Guidance

Section V.A.1

As part of the risk assessment, FDA recommends threat modeling be performed throughout the design process and be inclusive of all medical device system elements.

The threat model should:

  • Identify medical device system risks and mitigations as well as inform the pre- and post-mitigation risks considered as part of the Cybersecurity risk assessment;
  • State any assumptions about the medical device system or environment of use (e.g., hospital networks are inherently hostile, therefore manufacturers are recommended to assume that an adversary controls the network with the ability to alter, drop, and replay packets); and
  • Capture Cybersecurity risks introduced through the supply chain, manufacturing, deployment, interoperation with other devices, maintenance/update activities, and decommission activities that might otherwise be overlooked in a traditional safety risk assessment process

Medcrypt solution

Medcrypt offers threat modeling expertise and support as well as a full online training program that enables medical device engineers to learn about this useful security methodology and sharpen their skills in live labs.

Additionally, our Cybersecurity-enabled Quality Fabric (CeQ) provides an easy-to-follow template and model implementation of a threat model into a Secure Product Development Framework (SPDF), enabling medical device manufacturers to demonstrate compliance with evolving security regulations as well as ultimately produce more secure devices.

Cybersecurity Risk Assessment

FDA Guidance

Section V.A.2

Cybersecurity risks are difficult to predict, meaning that it is not possible to assess and quantify the likelihood of an incident occurring based on historical data or modelling (also known as a “probabilistic manner”).

FDA recommends that manufacturers assess identified risks according to the level of risk posed from the device and the system in which it operates.

Vulnerabilities identified in Cybersecurity and Infrastructure Security Agency (CISA) Known Exploited Vulnerabilities Catalog should be designed out of the device, as they are already being exploited and expose the medical device system and users to the risk.

Medcrypt solution

Medcrypt has developed a Cybersecurity-enabled Quality Fabric (CeQ) that provides an easy-to-follow template and model implementation of a Secure Product Development Framework (SPDF), enabling medical device manufacturers to demonstrate compliance with evolving security regulations as well as ultimately produce safer devices.

Interoperability Considerations

FDA Guidance

Section V.A.3

As part of a medical device system, a device may have Cybersecurity considerations
from interoperable functionality, including but not limited to interfaces with:

  • Other medical devices and accessories;
  • ‘Other functions’ as identified in the FDA’s guidance “Multiple Function Device Products: Policy and Considerations;”
  • Interoperability with healthcare infrastructure (e.g., network, Electronic Medical Records, medical imaging systems); and
  • General purpose computing platforms.

When common technology and communication protocols are used to enable interoperability (e.g., Bluetooth, Bluetooth Low Energy, network protocols), device manufacturers should assess whether added security controls beneath such communication are needed to ensure the safety and effectiveness of the device (e.g., added security controls beneath Bluetooth Low Energy to protect against risks if vulnerabilities in the Bluetooth Low Energy protocol or supporting technology are discovered).

Medcrypt solution

Medcrypt's FDA readiness includes a security architecture review, which would assess for communication protocols in place, and sufficiency of additional security controls under such communication protocols.

Medcrypt offers threat modeling expertise and support as well as a full online training program that enables medical device engineers to learn about this useful security methodology and sharpen their skills in live labs.

Third Party Software Components

FDA Guidance

Section V.A.4

Device manufacturers should document all software components of a device and address or otherwise mitigate risks associated with these software components.

In addition, under 21 CFR 820.50, a manufacturer must put in place processes and controls to ensure that its suppliers conform to the manufacturer’s requirements.

"...manufacturers should include plans for how third-party software components could be updated or replaced if support ends or other software issues arise in premarket submissions"

Medcrypt solution

Medcrypt's Cybersecurity-enabled Quality Fabric (CeQ) provides a model implementation that would include third-party component considerations.

Additionally, Helm, Medcrypt's vulnerability management solution, enables management of a system's software bill of materials including determining when vulnerabilities are relevant.

Software Bill of Materials (SBOM)

FDA Guidance

Section V.A.4.a

A robust SBOM includes both the device manufacturer-developed components and third party components, including purchased/licensed software and open-source software, and the upstream software dependencies that are required/depended upon by proprietary, purchased/licensed, and open-source software.  

An SBOM or an equivalent capability should be maintained as part of the device’s configuration management, be regularly updated to reflect any changes to the software in marketed devices, and should support documentation, such as the types detailed in 21 CFR 820.30(j) (Design History File) and 820.181 (Device Master Record).

Medcrypt solution

Helm, Medcrypt's vulnerability management solution, enables management of a system's software bill of materials, including determining when vulnerabilities are relevant, over the lifetime of a device.

Documentation Supporting SBOM

FDA Guidance

Section V.A.4.b

FDA’s guidance documents “Off-The-Shelf (OTS) Software Use in Medical Devices” and “Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software” describe information that should be provided in premarket submissions for software components for which a manufacturer cannot claim complete control of the software lifecycle. In addition to the information recommended in those guidance, manufacturers should provide machine readable SBOMs consistent with the minimum elements (also referred to as “baseline attributes”) identified in the October 2021 National Telecommunications and Information Administration (NTIA) Multistakeholder Process on Software Component Transparency document “Framing Software Component Transparency: Establishing a Common Software Bill of Materials (SBOM).”

In addition to the minimum elements identified by NTIA, for each software component contained within the SBOM, manufacturers should include in the premarket submission:

  • The software level of support provided through monitoring and maintenance from the software component manufacturer (e.g., the software is actively maintained, no longer maintained, abandoned); and
  • The software component’s end-of-support date.

As part of the premarket submission, manufacturers should also identify all known vulnerabilities associated with the device and the software components, including those identified in CISA’s Known Exploited Vulnerabilities Catalog.

For components with known vulnerabilities, device manufacturers should provide in premarket submissions:

  • A safety and security risk assessment of each known vulnerability (including device and system impacts); and
  • Details of applicable safety and security risk controls to address the vulnerability. If risk controls include compensating controls, those should be described in an appropriate level of detail.

Medcrypt solution

Medcrypt's Cyber security-enabled Quality Fabric (CeQ) provides a model implementation that would include third-party component considerations and architecture feedback.

Additionally, Helm, Medcrypt's vulnerability management solution, enables management of a system's software bill of materials including determining when vulnerabilities are relevant.

Security Assessment of Unresolved Anomalies

FDA Guidance

Section V.A.5

As a part of ensuring a complete security risk assessment under 21 CFR Part 820.30(g), the assessment for impacts to safety and effectiveness may include an assessment for the potential security impacts of anomalies. The assessment should also include consideration of any present Common Weakness Enumeration (CWE) categories.

Medcrypt solution

Helm, Medcrypt's vulnerability management solution, enables management of any present CWE categories.

TPLC Security Risk Management

FDA Guidance

Section V.A.6

FDA recommends that vulnerabilities be assessed for any differing impacts for all fielded versions to ensure patient risks are being accurately assessed.

At a minimum, FDA recommends tracking the following measures and metrics, or those that provide equivalent information:

  • Percentage of identified vulnerabilities that are updated or patched (defect density);
  • Duration from vulnerability identification to when it is updated or patched; and
  • Duration from when an update or patch is available to complete implementation in devices deployed in the field, to the extent known.

Averages of the above measures should be provided if multiple vulnerabilities are identified and addressed. These averages may be provided over multiple time frames based on volume or in response to process or procedure changes to increase efficiencies of these measures over time.

Medcrypt solution

Helm, Medcrypt's vulnerability management solution, enables metric measurement over the lifetime of a device.

Security Architecture

FDA Guidance

Section V.B

A security architecture definition process includes both high-level definitions of the devices and/or systems that interact, and detailed information on the implementations for how those interactions occur and are secured. It contains information that demonstrates that the risks considered during the risk management process are adequately controlled, which, in turn, supports the demonstration of the safety and effectiveness of the medical device system.

FDA recommends that these plans and procedures include design processes, design requirements, and acceptance criteria for the security architecture of the device such that they holistically address the Cybersecurity considerations for the device and the system in which the device operates.

Medcrypt solution

Medcrypt's Cybersecurity-enabled Quality Fabric (CeQ) would enable developing security architecture documentations and processes to support ongoing maintenance.

Security Architecture Views

FDA Guidance

Section V.B

The security architecture should include a consideration of system-level risks, including but not limited to risks related to the supply chain (e.g., to ensure the device remains free of malware, or vulnerabilities inherited from upstream dependencies such as third-party software, among others), design, production, and deployment (i.e., into a connected/networked environment).

If corrective and preventive actions are identified, these views can be used to help identify impacted functionality and solutions that address the risks.

Section V.B.2

FDA recommends providing, at minimum, the following types of views in premarketsubmissions:

  • Global System View;
  • Multi-Patient Harm View;
  • Updatability/Patchability View; and
  • Security Use Case View(s).

Appendix 2.A

These views should be sufficiently detailed such that engineers and reviewers should be able to logically and easily follow data, code, and commands from any asset (e.g., a manufacturer server) to any other associated asset (e.g., a medical device), while possibly crossing intermediate assets (e.g., application).

Appendix 2.B

This should include detailed diagrams and traces for all communication paths as described below. Security-relevant analysis requires the ability to construct and follow a detailed trace for important communication paths, which describes how data, code, and commands are protected between any two assets in the medical device system.

A precise, detailed list of how each type of credential (e.g., password, key) is generated, stored, configured, transferred, and maintained, including both manufacturer- and healthcare facility-controlled assets (e.g., key management and public key infrastructure (PKI))

Medcrypt solution

Medcrypt's Cybersecurity-enabled Quality Fabric (CeQ) would enable developing security architecture views, while our FDA readiness service will assess sufficiency of security architecture views related to a particular submission.

Additionally, our threat methodology, training and expertise support generating output that supports the architecture views required by the FDA.

Implementation of Security Controls

FDA Guidance

Section V.B.1

Effective Cybersecurity relies upon security being “built in” to a device, and not “bolted on” after the device is designed. FDA recommends that device manufacturers’ design processes include design inputs for Cybersecurity controls.

FDA recommends that an adequate set of security controls should include, but not necessarily be limited to, controls from the following categories:

  • Authentication;
  • Authorization;
  • Cryptography;
  • Code, Data, and Execution Integrity;
  • Confidentiality;
  • Event Detection and Logging;
  • Resiliency and Recovery; and
  • Updatability and Patchability.

FDA recommends the requirements and acceptance criteria for each of the above categories be provided in premarket submissions to demonstrate safety and effectiveness.

Medcrypt solution

Our Cybersecurity-enabled Quality Fabric (CeQ) provides an easy-to-follow template and model implementation of security control considerations into a Secure Product Development Framework (SPDF), enabling medical device manufacturers to demonstrate compliance with evolving security regulations as well as ultimately produce more secure devices.

Cybersecurity Testing

FDA Guidance

Section V.C

FDA recommends verification and validation include sufficient testing performed by the manufacturer on the Cybersecurity of the medical device system through which the manufacturer verifies and validates their inputs and outputs, as appropriate.

FDA recommends the following types of testing, among others, be provided in the submissions

A. Security requirements;
B. Threat mitigation;
C. Vulnerability testing;
D. Penetration testing

    For all testing, manufacturers should provide their assessment of any findings including rationales for not implementing or deferring any findings to future releases.

    For issues that will be addressed in future releases (i.e., remediation deferred for a future software release because current risk was assessed to be acceptable), the premarket submission should contain plans for those releases.

    FDA recommends that Cybersecurity testing should occur throughout the SPDF.

    Medcrypt solution

    Our Cybersecurity Quality Fabric (CQ) provides an easy-to-follow template and model implementation of security testing considerations into a Secure Product Development Framework (SPDF).

    Labeling Recommendations

    FDA Guidance

    Section VI.A

    FDA also believes that informing users of security information through labeling may be an important part of design and development activities to help mitigate Cybersecurity risks and help ensure the continued safety and effectiveness of the device.

    Specific guidance to users regarding supporting infrastructure requirements so that the device can operate as intended (e.g., minimum networking requirements, supported encryption interfaces). Where appropriate, such guidance should include technical instructions to permit secure network deployment and servicing, and instructions for users on how to respond upon detection of a Cybersecurity vulnerability or incident.

    A revision-controlled, Manufacturer Disclosure Statement for Medical Device Security (MDS2)66 and Customer Security Documentation as outlined in the Medical Device and Health IT Joint Security Plan (JSP)67 may address a number of the above recommendations.

    Medcrypt solution

    Our Cybersecurity Quality Fabric (CQ) provides a template specific to customer documentation requirements, and model implementation of labeling needs into a Secure Product Development Framework (SPDF).

    Cybersecurity Management Plans

    FDA Guidance

    Section VI.B

    FDA recommends that manufacturers establish a plan for how they will identify and communicate to users vulnerabilities that are identified after releasing the device in accordance with the 21 CFR 820.100. This plan can also support security risk management processes that are described throughout the QS regulation.

    Cybersecurity management plans should include the following elements:

    • Personnel responsible;
    • Sources, methods, and frequency for monitoring and identifying vulnerabilities (e.g., researchers, NIST national vulnerability database (NIST NVD), third-party software manufacturers);
    • Identify and address vulnerabilities identified in CISA Known Exploited Vulnerabilities Catalog;
    • Periodic security testing;
    • Timeline to develop and release patches;
    • Update processes;
    • Patching capability (i.e., rate at which update can be delivered to devices);
    • Description of their coordinated vulnerability disclosure process; and
    • Description of how the manufacturer intends to communicate forthcoming remediations, patches, and updates to customers.

    Medcrypt solution

    Medcrypt's Cybersecurity-enabled Quality Fabric (CeQ) provides a model implementation that would include third-party component considerations and architecture feedback.

    Additionally, Helm, Medcrypt's vulnerability management solution, enables management of a system's software bill of materials including determining when vulnerabilities are relevant, over the lifetime of the device.

    Authentication

    FDA Guidance

    Appendix 1.A

    There are generally two types of authentication controls—information and entities—and a properly-secured system is able to prove the existence of both.

    A medical device system that appropriately accounts for authenticity can evaluate and ensure authenticity for:

    • Information at rest (stored);
    • Information in transit (transmitted);
    • Entity authentication of communication endpoints, whether those endpoints consist of software or hardware;
    • Software binaries;
    • Integrity of the execution state of currently running software; and
    • Any other appropriate parts of the medical device system where a manufacturer’s threat model and/or risk analyses reveal the need for it.

    Medcrypt solution

    Using Medcrypt Guardian, authenticity can be evaluated and ensured, for example a user can verify data at rest, use Guardian for mutual TLS and similar.

    Authorization

    FDA Guidance

    Appendix 1.B

    Within an adequately designed authorization scheme, the principle of least privileges should be applied to users, system functions, and others, to only allow those entities the levels of system access necessary to perform a specific function.

    While authentication schemes based on cryptographically proven designs are generally considered more robust and are therefore preferred, meaningful authorization checks can be performed based on other compelling evidence

    Medcrypt solution

    Medcrypt offers threat modeling expertise and support as well as a full online training program that enables medical device engineers to apply authentication best practices to their devices.

    Medcrypt-enabled devices send system event metadata to an monitoring system that is located in the cloud, and these events can be monitored for suspicious behavior in tools such as a SIEM, which can be used to inform the detection of device behavior anomalies.

    Cryptography

    FDA Guidance

    Appendix 1.A

    When choosing an authentication scheme, manufacturers should keep in mind the following
    generally applicable characteristics of different types of schemes:

    • Implicit authentication schemes, based solely on non-cryptographic interfaces, handshakes, and/or protocols, are inherently weak because, once they are reverse engineered, an unauthorized user can easily emulate the correct behaviour and appear to be authorized.
    • Cryptographic authentication protocols are generally superior, but they need careful design choices and implementation practices to achieve their full strength. In addition, these schemes are still limited by the confidentiality of the cryptographic keys needed to interact with the scheme, and by the integrity of the devices that hold or otherwise leverage those keys

    Appendix 1.C

    Cryptographic algorithms and protocols are recommended to be implemented to achieve the secure by design objectives outlined in Section IV. While high-quality, standardized cryptographic algorithms and protocols are readily available, several commercial products that include cryptographic protections have been shown to have exploitable vulnerabilities due to improper configurations and/or implementations.

    Design a system architecture and implement security controls to prevent a situation where the full compromise of any single device can result in the ability to reveal keys for other devices.

    Medcrypt solution

    Medcrypt Guardian abstracts the complexity of configuration and/or implementation of cryptography authentication implementations, while enabling security controls that accommodate medical device development and manufacturing practices.

    Medcrypt makes it easy to have each endpoint in your medical device utilize cryptographic authentication algorithms and protocols to achieve the secure by design objectives.

    Code, Data, and Execution Integrity

    FDA Guidance

    Appendix 1.D

    Allow installation of cryptographically authenticated firmware and software updates, and do not allow installation where such cryptographic authentication either is absent or fails. Use cryptographically signed updates to help prevent any unauthorized reductions in the level of protection (downgrade or rollback attacks) by ensuring that the new update represents an authorized version change;

    Cryptographic authentication schemes verify data integrity, but do not verify data validity. Therefore, the integrity of all incoming data should be verified to ensure that it is not modified in transit or at rest;

    Carefully design and review all code that handles the parsing of external data using automated (e.g., static and dynamic analyses) and manual (i.e., code review) methods.

    Medcrypt solution

    Medcrypt's Guardian can be used to cryptographically authenticate firmware and software updates by allowing explicit sign and verify functions on each data payload. This results in the implementation of our cryptography solution being used to confirm data is not modified in transit or at rest.

    Confidentiality

    FDA Guidance

    Appendix 1.E

    Manufacturers should ensure support for the confidentiality of any/all data whose disclosure could lead to patient harm (e.g., through the unauthorized use of otherwise valid credentials, lack of encryption). Loss of confidentiality of credentials could be used by a threat-actor to effect multi-patient harm. Lack of encryption to protect sensitive information and or data at rest and in transit can expose this information to misuse that can lead to patient harm. For example, confidentiality is required in the handling and storage of cryptographic keys used for authentication because disclosure could lead to unauthorized use/abuse of device functionality.

    Medcrypt solution

    Medcrypt Guardian abstracts the complexity of configuration and/or implementation of cryptography protections, including public key infrastructure to support handling and storage of cryptographic keys that are used for authentication.

    Event Detection and Logging

    FDA Guidance

    Appendix 1.F

    Event detection and logging are critical capabilities that should be present in a device and the larger system in which it operates in order to ensure that suspected and successful attempts to compromise a medical device may be identified and tracked.

    While many of the following recommendations are tailored for workstations, the concepts presented also apply to embedded computing devices.

    Implement design features that allow for security compromises and suspected compromise attempts to be detected, recognized, logged, timed, and acted upon during normal use.

    Ensure the design enables forensic evidence capture.

    Medcrypt solution

    Medcrypt-enabled devices send system event metadata to an monitoring system that is located in the cloud, and these events can be monitored for suspicious behavior in tools such as a SIEM, which can be used to inform the detection of device behavior anomalies.

    Resiliency and Recovery

    FDA Guidance

    Appendix 1.G

    Devices should be designed to be resilient to possible cyber incident scenarios (also known as “cyber-resiliency”) and maintain availability.

    Implement features that protect critical functionality and data, even when the device has been partially compromised.

    Medcrypt solution

    Medcrypt's Cybersecurity-enabled Quality Fabric (CeQ) provides an engineering practices and principles document that includes 'design for resiliency' requirements.

    Firmware and Software Updates

    FDA Guidance

    Appendix 1.H

    Devices should be capable of being updated in a secure and timely manner to maintain safety and effectiveness throughout the product’s lifecycle.

    Design devices to anticipate the need for software and firmware patches and updates to address future Cybersecurity vulnerabilities. This will likely necessitate the need for additional storage space and processing resources.

    Medcrypt solution

    Medcrypt Guardian can be used to sign and verify updates to devices throughout the product lifecycle.

    Ensure your devices are secure by design with a comprehensive cybersecurity solution that meets FDA requirements and guidelines

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