Focus Area

Comprehensive Security Solutions for the Medical Device Industry

We offer a comprehensive portfolio of services and technology to help you achieve compliance with all the regulations and standards for your medical device from start to finish. This ensures that your device remains safe and effective for both healthcare providers and patients throughout its entire lifecycle, from pre-market approval through post-market surveillance.

Standards

Comply with regulations

We support Medical Device Manufacturers and Health Delivery Organizations in reaching the security objectives of key standards and regulations:

MDR EU 2017/745
IEC 62443-4-1
FDA Class I, II, or III devices
ISO 14971
UL 2900-2-1

Offerings

Services and solutions to secure every stage of your MDM journey

With our expertise in threat analysis, code review, device evaluation, key management, provisioning, over-the-air firmware updates, continuous monitoring and incident response, we ensure you meet your security objectives at every phase of your medical device's product lifecycle

We work with you to understand your risks and assess your software and hardware so you can submit robust, third-party expert evidence demonstrating the safety and security of your medical device or ecosystem and achieve Premarket Approval (PMA).

Premarket submission / regulations requirements

We provide the comprehensive reports and documentation of the security measures, tests, and validations performed, suitable for submission to regulatory bodies like FDA.
We help you continuously monitor and report on your product's security performance in the market, including specific security incidents and other potential vulnerabilities that arise as the threat environment evolves.

Post-market surveillance & regulation requirements

Leverage our expertise in security, compliance and cybersecurity monitoring to help meet your PMS obligations.
Delta Code Reviews on Updates
Incident Response
Our advanced medical device security services go above and beyond mandatory requirements, focusing on security by design, product longevity, and protecting innovation and IP.

Advanced medical device security services

Enhance device security for sensitive applications, protect your valuable intellectional property and ensure the integrity of your selected components with the help of our experts.
Advanced Security Evaluation
Advisory for Semiconductor BOM
IP Protection
Take control of the security of your medical devices with our battle-tested and market-ready technologies, empowering you to effectively manage, update, and maintain control over your devices.

Medical device security technologies

Our technologies enable you to securely onboard, manage, update and control your devices over-the-air, providing the protection you need to achieve protect your end-users, your brand and your revenue.

EXPERTISE & USE CASES

An active and trusted partner to the Medical Device industry

We provide comprehensive security solutions and expertise to a range of medical device manufacturers, and have helped them quantify and mitigate their risks while providing expert evidence for diverse compliance processes.

Outcome

Kudleski IoT discovered vulnerabilities in the customer's ecosystem that could have resulted in leakage of patient data. A report was provided and the client was able to implement remediations to prevent the threat.

Our services

Device Security Discovery
White Hat Security Evaluation

Outcome

Kudelski IoT discovered security gaps that would have circumvented protections against the use of third-party conumables, thereby harming the client's business model.

Our services

Threat Assessment $ Risk Analysis
Penetration Testing

Outcome

Kudelski IoT was able to assure the MDM customer the their chosen communications module provided sufficient protection against identified security threats and was the right choice for their BOM.

Our services

System-wide Security Architecture ReviewThreat Assessment and Risk AnalysisDevice Security Discovery

Outcome

Kudelski IoT identified vulnerabilities in the communication between the hearing aid and its associated smartphone app that would have allowed for malicious software to be loaded onto the device. Remediations were recommended.

Our services

Threat assessment
App audit and code review
Cloud penetration testing

Outcome

Kudelski IoT worked with the client to design a secure architecture and lifecycle management strategies that would ensure the long-term security of the device.

Our services

Threat Assessment & Risk Analysis
Architecture Review
Security Module Integration
Provisioning & Credential Management

NAVIGATING MDM COMPLIANCE

Ensure compliance while securing your business and patients

We enable MDMs to focus on their core business while relying on our seasoned security staff for compliance and protection expertise. Achieve a trusted level of cybersecurity, manage risks, and ensure compliance with stringent and evolving regulatory requirements.

We help you understand and manage:

Regulatory changes

EU: Medical Device Regulation EU 2017/745 Enforced since May 2021, but grace period until May 2024

US: Section 524B of the Food & Drug Omnibus of Dec ’22 (section 3305)
Enforced from October 2023

External implications

Liabilities
Brand image
Preservation of IP value
Compliance with regulations

Internal safety needs

Patient safety
Sensitive data safety
Intellectual property
Medical Fact Sheet

Fact Sheet

Comprehensive Security Solutions for the Medical Device Industry

We provide the services and secure foundations that will help you achieve compliance and manage your medical device throughout its entire lifetime, ensuring it continues to meet both emerging regulations and patient and provider needs.

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Medical White Paper

White Paper

Navigating Emerging Standards and Regulations: A Guide for Medical Device Manufacturers

This white paper aims to provide a comprehensive understanding of the emerging standards and regulations in the market that govern medical device cybersecurity.

Get the PDF

BENEFITS

Why is medical device security so important?

Securing Medical Devices: Compliance with Regulatory Standards and Ensuring Patient Safety for Manufacturers

Secure your medical devices to protect the life and health of your end-users

Medical devices are an integral part of patient care, with many devices directly impacting the health and well-being of the users. Ensuring their security isn't just a technical concern, but a matter of life and health. High-grade security protects against malicious interference that could compromise the device's operation, potentially causing harm or even fatal outcomes. As such, security measures play a vital role in safeguarding the health of end-users.

Secure medical devices to prevent them from being the weak link for attackers to reach further assets

In a networked environment, an insecure medical device can act as a gateway for attackers to infiltrate other connected systems. This could lead to broader breaches involving data theft or disruption of other critical systems. By securing medical devices, manufacturers can prevent them from becoming the weak link in the chain, thereby protecting not only the device itself but also the broader network it's part of.

Secure your medical devices to guarantee correct operation with maximal uptime

Security breaches can lead to device malfunction or downtime, which can have significant consequences in a healthcare setting. By securing medical devices, manufacturers ensure their correct, uninterrupted operation. This not only provides consistency in delivering healthcare services but also builds trust with healthcare providers and patients.

Secure your medical devices to defend your Intellectual Property and revenues

Medical devices often involve proprietary technology and processes that represent significant investment. Ensuring robust security helps to protect this intellectual property from theft or unauthorized use, safeguarding the manufacturer's business model and revenue streams. This is especially important in a competitive market, where innovations provide a key differentiator.

Secure your medical devices to safeguard your users’ privacy and data

Medical devices often handle sensitive data, including personal and health information. Security breaches could lead to privacy violations with serious legal and reputational consequences. By securing their devices, manufacturers can ensure the privacy and confidentiality of user data, building trust with patients and complying with privacy regulations.

Secure your medical devices to demonstrate provable due diligence and lessen liabilities

Implementing robust security measures shows due diligence on the part of the manufacturer. This not only builds trust with stakeholders but also reduces potential liabilities in case of security incidents. In an environment of increasing regulatory scrutiny, the ability to demonstrate robust security practices is becoming increasingly important.

Secure your medical devices to anticipate evolving certification requirements

Regulations and certification requirements around medical device security are continually evolving. By proactively securing devices and staying abreast of the latest security practices, manufacturers can anticipate and meet these changing requirements. This not only ensures continued compliance but also avoids the potential costs and disruptions of having to retrofit security measures in response to new regulations.

Secure your medical devices to mitigate future threats and new menaces

The cybersecurity landscape is continually changing, with new threats emerging all the time. By implementing robust, adaptable security measures, manufacturers can better prepare for these future threats. This proactive approach to security helps to ensure the ongoing safety and effectiveness of medical devices, even in the face of new and unexpected security challenges.

Secure your medical devices to fill the gap between electronic and mechanic excellence and IT-based security

Medical devices represent the perfect intersection of mechanical and electronic engineering, often functioning flawlessly in their designated roles. However, with the increasing integration of IT elements and network connectivity, they face a host of new security challenges that traditional engineering disciplines are not equipped to handle. By implementing robust IT-based security measures, manufacturers can bridge this gap. They can ensure that their devices not only excel in their mechanical and electronic functions but are also resilient to cyber threats, thereby providing a comprehensive level of safety and effectiveness.

GET IN TOUCH

Contact us to learn more

For more information about our Medical Device Security technologies and services, please fill in this form and we will put you in touch with the right expert.

F.A.Q

About Medical Device Security

Here are the most important questions related to MDM security and their answers.

What are the key security regulations that medical device manufacturers need to comply with?

Medical device manufacturers (MDMs) need to comply with regulations such as the Medical Device Regulation (MDR EU 2017/745), FDA Class I, II, or III requirements, IEC 62443-4-1 for industrial control system security, ISO 14971 for risk management, and UL 2900-2-1 for healthcare system cybersecurity.

Why is compliance with security regulations important for medical device manufacturers?

Compliance with security regulations is essential for medical device manufacturers to ensure patient safety, protect sensitive data, maintain market access, and preserve their reputation. Non-compliance can result in regulatory penalties, legal consequences, and compromised patient well-being.

How can security vulnerabilities in medical devices impact patient health and safety?

Security vulnerabilities in medical devices can be exploited by malicious actors to manipulate device functionality, administer drug overdoses, or provide inaccurate readings, thereby endangering patient health and safety.

How can external security experts assist medical device manufacturers in achieving compliance with security regulations?

External security experts can provide specialized services to assist medical device manufacturers in achieving compliance. These services may include threat and risk analysis, code review, device security evaluation, security evaluation techniques, architecture review, intellectual property protection, and continuous monitoring.

What is the process of conducting a threat and risk analysis for medical devices?

A threat and risk analysis involves assessing potential security threats, identifying vulnerabilities, and evaluating the associated risks for medical devices. This process helps MDMs understand their device's security posture and develop strategies to mitigate potential risks.

How do code reviews enhance the security of medical devices?

Code reviews involve analyzing the software code of medical devices to identify security flaws and vulnerabilities. This practice helps uncover potential weaknesses and enables the implementation of secure coding practices to strengthen device security.

What is the significance of device security evaluation for medical device manufacturers?

Device security evaluation is crucial for medical device manufacturers to assess the overall security of their devices. It helps identify potential vulnerabilities, implement robust security measures, and ensure compliance with required security standards and regulations.

How can external experts support medical device manufacturers in managing risks and reaching a trusted level of cybersecurity?

External experts can provide comprehensive premarket and postmarket services to help medical device manufacturers manage risks and achieve a trusted level of cybersecurity. These services may include threat and risk analysis, code review, device security evaluation, incident response, and continuous monitoring.

What are the benefits of partnering with external security providers for security and compliance needs?

Partnering with external security providers allows medical device manufacturers to leverage specialized expertise in security and compliance. It enables MDMs to focus on their core business while relying on external support to address cybersecurity challenges, ensure compliance, and enhance the security of their devices.

Can external experts assist with securing intellectual property and conducting patent infringement analysis for medical device manufacturers?

Yes, external security providers can offer services to protect intellectual property and conduct patent infringement analysis. They can help MDMs safeguard their innovations, identify potential infringements, and mitigate risks related to patent infringement.

How do external security providers stay up to date with evolving security regulations and standards?

External security providers stay up to date with evolving security regulations and standards through continuous monitoring, active participation in industry forums, engagement with regulatory bodies, and ongoing research. This ensures that their services align with the latest requirements.

What are the potential consequences of non-compliance with security regulations for medical device manufacturers?

Non-compliance with security regulations can lead to regulatory sanctions, legal liabilities, loss of market access, damage to reputation, and compromised patient safety. It is crucial for MDMs to prioritize compliance to mitigate these risks.

Can external security providers assist with security-related incident response and recovery?

Yes, external security providers can offer incident response services to assist medical device manufacturers in handling security incidents effectively. They provide guidance on incident containment, investigation, recovery, and steps to prevent future incidents.

How can medical device manufacturers ensure the continuous security of their devices after the initial compliance process?

Continuous monitoring, firmware updates, and patches are essential to ensure the ongoing security of medical devices. External security providers can offer solutions for monitoring firmware, detecting vulnerabilities, and providing timely updates and patches to address emerging threats.

What is the significance of fault injection and side-channel analysis in security evaluation?

Fault injection and side-channel analysis are advanced techniques used to assess the resilience of medical devices against sophisticated attacks. These techniques help identify potential vulnerabilities and improve the overall security posture of the devices.

How can quantum-resistant cryptography benefit the security of medical devices?

Implementing quantum-resistant cryptography in medical devices provides enhanced protection against attacks from quantum computers. It ensures the long-term security and confidentiality of sensitive data transmitted and stored within the devices.

Can external security providers assist with architecture review and advisory for semiconductor Bill of Materials (BOM)?

Yes, external security providers can offer architecture review services to assess the overall design and structure of medical devices. They can also provide advisory support for semiconductor BOM, helping MDMs make informed decisions regarding components' security and potential vulnerabilities.

How can medical device manufacturers stay protected from emerging vulnerabilities and evolving cyber threats?

Staying proactive and up to date with emerging vulnerabilities and evolving cyber threats is essential. Medical device manufacturers can seek support from external security providers to receive ongoing monitoring, updates, and timely guidance to address emerging security challenges.

What steps should medical device manufacturers take to enhance security and compliance with the help of external providers?

Medical device manufacturers can start by researching and selecting reputable external security providers who offer specialized services tailored to their needs. They should then collaborate closely with the provider, communicate their requirements, and work together to implement robust security measures and ensure compliance.

How can medical device manufacturers initiate a partnership with an external security provider for their security and compliance needs?

Medical device manufacturers can initiate a partnership with an external security provider by reaching out to their team through the contact information provided on their website. The security provider's experts will guide MDMs through the process, understand their specific needs, and tailor their services to support their security and compliance objectives.

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