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Medical Device Security

Testing and Certification

Raise the bar of your product's brand, security, and reliability through enhanced device integrity.

Ensure your FDA submission supports the necessary requirements for a successful approval. 

A threat-adoptive approach to cybersecurity

For healthcare organizations,  the security of connected medical devices is paramount to protecting patient safety, ensuring data privacy, and maintaining operational integrity. The growing sophistication of cyber-attacks requires a threat-adaptive approach to device cybersecurity throughout the total product lifecycle (TPLC).

Palindrome’s product security assurance expertise provides a threat-adoptive approach to ensuring your product lifecycle and implementation adhere to industry and federal requirements, including IEEE 2621, ISA 62443, ISO 18045 among others, while maintaining robust security controls against emerging threats.  
Palindrome’s device security testing and assurance capabilities identify gaps in product development processes and implementation vulnerabilities that can compromise product integrity.

 

Areas of support include: 

  • Secure Product Lifecycle Audit: Identify gaps in your Product Development Life Cycle (PDLC) and enhance processes and procedures to improve your product’s security profile.  
  • Secure Product Development Framework(SPDF): Assist with developing or enhancing your  processes and procedures that support security in your product development lifecycle (e.g., design and development, to release, support, and decommission) to provide Cybersecurity assurance. 
  • Device Security Certification: Conduct security testing and certify to industry security standards (i.e., FDA , IEEE) 
  • Product Security Analysis and Penetration Testing: Offers greater testing coverage from an adversarial perspective including, but not limited to, threat modeling, hardware analysis, firmware analysis, platform analysis, third-party components and SBOM analysis, function-containerization, API and signaling protocol analysis. 
Palindrome works with your team to understand requirements and priorities, both tactical and strategic, and develop a roadmap to help you achieve product security assurance and certification goals with clarity. 

Medical Device Cybersecurity Certification: Your Path to Compliance 

Developed by the IEEE 2621 Conformity Assessment Committee (CAC), this program addresses cybersecurity risks in devices that capture and manage user biodata and impact quality of life. The IEEE 2621 certification helps manufacturers meet FDA submission criteria and other global regulatory requirements. 

Medical devices face unique cybersecurity challenges as the interface between the human body and computerized systems. Common areas of attack include, but are not limited to: 

  • Weak encryption  
  • Wireless signal interception  
  • Software vulnerabilities exploitation  
  • Data transmission interception  
  • Service disruption  

 Exploitation of device vulnerabilities or companion software can lead to severe consequences, including altered drug dosages, falsified vital signs, and compromised patient data. 

 

 

Prepare for FDA 510k pre-market submission 

 

Per FDA, as more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effectiveness includes adequate medical device cybersecurity, as well as its security as part of the larger system. 

Managing the security risks throughout the life cycle of a medical device can be a daunting task for a product team, especially when resource limitations often choke the teams' ability to reduce time to market and struggle to keep up with the latest attack vectors and industry best practices due to rapidly evolving threat and vulnerability landscapes.

We partner with customers to:

  • Assist with managing security in product lifecycle effectively and efficiently
  • Identify risks and offer recommendations for remediation
  • Enhance consumer trust and confidence
  • Demonstrate commitment to product security assurance and due diligence 

The core purpose of implementing a Secure Product Development Framework is to maintain continuous trustworthiness and resilience in the development process.  

To ensure adherence with industry standards and current best practices, the Product Lifecycle Security Audit  is designed to verify Security by design practices (e.g., Domain separation, Least Privilege, Attack Surface Minimization, Vulnerability Disclosure) including: 

  • Design Process
  • Implementation process 
  • Building process
  • Testing process 
  • Release process 
  • Operation process 
  • Maintenance process 
  • Vulnerability Management 
  • Supply Chain Risk Management 

Whether you need third party attestation to demonstrate conformance with industry standards or security certification, we guide you through every step of the process, helping you align with industry best practices and standards that set your products apart in the market. 

We offer a range of certification options to meet your specific needs, including: 

  • US FDA Medical Device Cybersecurity Conformance 

 To mature your security lifecycle and maintain a diligent cybersecurity posture, we conduct specific knowledge transfer sessions and training.

The Security Analysis and Penetration Testing effort is designed to provide greater testing coverage from an adversarial perspective.

The scope can focus on specific areas or extend including, but not limited to:  

  • Threat Modeling 
  • Hardware Security Analysis 
  • Firmware Security Analysis 
  • Operating System Security Configuration Analysis 
  • Network and Application API Security Analysis 
  • Web Application Security Analysis 
  • Signaling Protocol Analysis (e.g., end-to-end Call-Flow Analysis) 
  • Software Bill of Material (SBOM) Security Analysis  
  • Virtualization and Containerization Security Analysis 

Security Lifecycle Surveillance Activities

  • Annual Security Product Lifecycle Risk Assessment
  • Ad-hoc security testing for specific product enhancements
  • OSINT and Attack Surface Monitoring
  • Annual product security assessments 
  • On Demand Firmware Security Analysis 

Why Choose Palindrome Technologies? 

 

As an ISO-accredited security testing lab with over two decades of experience, Palindrome guides organizations through rigorous certification processes, including FCC, GSMA, NIST, IEEE, ETSI, CTIA, and ISA standards. Our expertise in emerging technologies, including 5G, and IoT, positions us at the forefront of cybersecurity, enabling us to anticipate and mitigate potential threats in your products.  

By partnering with Palindrome, you gain access to our Symmetric Defense approach, which combines in-depth expertise with cutting–edge research to identify and eliminate weaknesses across all attack surfaces.  

As a Cybersecurity Label Administrator and Testing Lab for the FCC’s IoT program, we are uniquely positioned to enhance your product security and build consumer trust. Choose Palindrome to prepare for cybersecurity challenges, safeguard your reputation and demonstrate due diligence.  

 

Start Securing Your Critical Infrastructure   

 

Leaving your mission-critical systems vulnerable can impact your reputation and cripple your market reach.  

Palindrome Technologies can help you not only meet regulatory requirements but also demonstrate the highest levels of assurance to stakeholders and your commitment to keep your customers secure.

 

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