GRC Certification is designed to assess the resilience of a system against attacks and unauthorized access.
We provide a wide range of penetration testing services.
Gap Analysis
Additionally, GRC Certification ensures that products meet specific standards or guidelines required by regulatory bodies.
We can support manufacturers worldwide by ensuring compliance.
What is Medical Device Cybersecurity?
Cybersecurity of medical devices plays a critical role in protecting patient data and lives.
It is also essential to protect healthcare institutions from ransomware attacks.
As medical devices and their connectivity evolve,
Cyber threats are also evolving accordingly, creating new risks.
CYBERSECURITY FOR MEDICAL DEVICES
Why is medical device cybersecurity
important?
Cybersecurity risks for medical devices are multifaceted, so it is important to adhere to the latest certifications and standards and undergo a thorough cybersecurity assessment.
Effective risk management identifies vulnerabilities throughout the life cycle,
Medical Device Cybersecurity Risks and Requirements
Regulatory requirements
Medical devices are subject to strict regulation by regulatory agencies such as the FDA in the United States, the MDR in Europe, and the NMPA in China.
These regulations protect devices from hacking and other cyber threats. If a device, such as a pacemaker or insulin pump, is hacked, it could malfunction, deliver the wrong treatment dose, or not work properly at a critical moment.
To keep you safe, you must adhere to certain cybersecurity standards and guidelines.
Failure to comply with regulations may result in sanctions including significant fines, recalls, or sales bans.
Patient Safety
Cybersecurity vulnerabilities in medical devices threaten patient safety.
It can be a direct threat.
When devices such as pacemakers or insulin pumps are hacked,
Causes malfunction and provides incorrect therapeutic doses; or
It may not work properly at critical moments.
Privacy and
Service Interruption Risks
Because medical devices often store and transmit sensitive health information,
Security breaches can expose your personal health records, leading to identity theft and
This may lead to loss of patient confidential information.
This allows malicious actors to encrypt sensitive data and then use it to unlock it.
This is a common risk with ransomware attacks that demand a ransom.
These attacks not only violate patient privacy,
Disrupting the essential operation of the health care system;
It highlights the urgent need for strong cybersecurity measures.
Medical Device Cybersecurity Standards and Guidelines
Medical Device Cybersecurity Regulation
Cybersecurity of medical devices is regulated by international and national standards.
They are thoroughly tested. They may malfunction, deliver the wrong therapeutic dose, or fail to work properly at a critical moment.
Regulatory bodies around the world are regulating medical device cybersecurity.
We are publishing guidelines,
It specifies the testing procedures required for market entry.
Medical Device Cybersecurity Guidelines
GRC Certification Institute supports the following standards:
Europe / MDCG 2019-16 EU Medical Device Cybersecurity Directive: Ensuring the integrity and confidentiality of medical device data across the European market. US / US FDA Guidance on Cybersecurity of Medical Devices - Quality System
Considerations and Premarket Submissions: Guidance for integrating cybersecurity measures from design through deployment within the US regulatory framework. International / IEC TR 60601-4-5 Medical Device Cybersecurity Standard for
Cybersecurity: Technology Roadmap for Implementing Global Cybersecurity Standards in Medical Devices International / IEC 81001-5-1 Standard for security activities in the product life cycle of
health software and health IT systems: A strategy for maintaining cybersecurity throughout the operational life of a device, applicable globally.
Medical Device Cybersecurity Testing
Cybersecurity testing required by FDA
Designed to ensure the security and effectiveness of medical devices.
The various steps included below:
Security Requirements
Manufacturers must provide evidence that the security requirements defined during threat modeling have been implemented at the product level.
Manufacturers must provide evidence of how these security requirements have been correctly implemented, as well as an analysis and justification of boundary assumptions.
Threat Mitigation (manufacturer performed)
Manufacturers provide evidence demonstrating effective risk management measures based on the threat model provided. Manufacturers must provide a means to verify
that each cybersecurity risk control is appropriate (e.g., the effectiveness of security in enforcing a specified security policy).
Provide evidence of performance, stability and reliability under peak traffic conditions.
Vulnerability testing (performed by the manufacturer or a specialized agency)
The various steps included below:
You must provide evidence:
Robustness
Fuzzing test
Static and dynamic code analysis
Attack Surface Analysis
Closed testing for known vulnerability scanning Analyzing the software composition of
previous executables
Performed by a professional organization
Security issues should be identified and characterized through testing by independent third-party organizations that focuses on discovering and exploiting security vulnerabilities.
A penetration test should include the following elements:
Tester independence and technical expertise
Test scope and period
How to test
Test Results
Report a test defect
Why choose GRC?
Penetration Testing
GRC Certification certifies the resilience of a system against attacks and unauthorized access.
We offer a wide range of penetration testing services to evaluate:
We perform cyber attack simulations across a variety of components.
Assess the vulnerability of medical devices.
About hardware
Cutting-edge attacks and ad hoc tools created by lab experts
Reverse Engineering
Design Review
Logical Attack Analysis
Repository Extraction and External Analysis
About software and firmware
Strong background in embedded systems, secure boot, TEE and whitebox cryptography
Binary Reverse Engineering
Static attack
Source code review
Debugging
Purging
Dynamic Tamper/Hooking
About communication protocols
For IP stack protocols, industrial systems and proprietary protocols.
All layer attacks (OSI model) including custom HW for stimulation at lower layers (wired and wireless protocols)
Purging
GRC Certification Institute's expertise in cybersecurity
We further strengthen the security measures we recommend.
Penetration testing activities performed in our expert Lab include:
Not only does it help strengthen the cyber resilience of your products,
Required by global regulatory agencies such as the US FDA
Serves as evidence of compliance with cybersecurity requirements.
Gap Analysis
Additionally, GRC certification is required by regulatory agencies.
Verify that the product complies with specific standards or guidelines.
We can support manufacturers worldwide.
Review documentation produced by manufacturers to ensure they meet specific standards;
Identify gaps or potential problems.
At this stage, the testing team will submit the results to the regulatory agency.
To prepare the necessary documentation for the manufacturer
Analyze, guide and support.
For example, for FDA cybersecurity testing, a specialized testing team is required prior to premarket submission.
We offer an optional service to review manufacturer documentation.
This service is .
① Focus on security requirements ② Threat mitigation ③ Vulnerability testing
Analyze the defined security requirements and identify security issues and problems in threat modeling.
Verify the suitability of defined hypotheses, vulnerability testing, etc.
Project and Product Experience
Software as a Medical Device (SaMD)
PACS (Picture Archiving and Communication System)
surgical planning software
Surgical Navigation System Software
Radiation Therapy Planning System
Pelvic floor muscle assessment training software
IVD Data Interpretation Software
Medical Device Mobile App
Other software-only medical devices
Software embedded in a medical device (SiMD: Software in a Medical Device)
