Medical Cybersecurity

FDA Cybersecurity in Medical Devices


FDA Cybersecurity Compliance Solution

Onward Security provides cybersecurity testing services to verify whether the medical devices meet the security compliance claimed by the customers. We provide FDA medical device cybersecurity technical testing services, covering performance testing (such as the external connection of the device itself, whether to do connection control), third-party applications (mobile app, cloud, and more), or kits security testing (establishment list of device OS, applications, kits, etc.), static and dynamic analysis (providing source code detection, penetration testing, fuzzing, etc. .). Once the test is completed, a report will be issued, informing the high, medium, or low levels of risk and vulnerability, repair suggestions, and more, as well as overall compliance with FDA cybersecurity requirements.

Why Medical Cybersecurity?

Why Medical Cybersecurity?
FDA Cybersecurity Document 2014 Customer Provides Documents Onward Security Services
Cybersecurity Risks and Control Product Spec, SRS, SDD, and Related Design Documents Risk Assessment Report
Traceability Matrix Traceability Matrix Cybersecurity Traceability Matrix
Software / Patch Update Plan Software / Patch Update Plan Cybersecurity Software / Patch Update Plan
Software Integrity Control Existing Relevant Policies Provide Practical Industry Control Specifications / Reference Documents and Consultation
Cybersecurity Environment Instructions User Manual Provide Related Reference Documents and Consultation

Assist Customers to Produce Relevant Documents that Meet FDA Requirements

1. Risk Assessment Report
  • Microsoft Threat Modeling
  • Use the STRIDE Method to Sort Out the Security Risks and Corresponding Improvement Measures

2. Cybersecurity Traceability Matrix
  • Verify SRS, SDD and Other Related Design Documents
  • Organize Existing Related Network Security Projects

3. Software / Patch Update Plan
  • Provide Release Process of Industry Security Software
  • Suggest to Improve the Existing Software Release Plan

4. Software Integrity Control
  • Organize the Current Measures Regarding the "Integrity" of Medical Products (Software/Product)
  • Provide Improvement Suggestions and Practical Reference of Industry Management and Control Standards

5. Cybersecurity Environment Instructions
  • Organize the Current Measures Regarding the "Usage Environment" of Medical Products
  • Provide Improvement Suggestions and Practical Reference of Industry Management and Control Standards
FDA Cybersecurity

Learn More About FDA Cybersecurity

1. Attack Models
  • Think like the attacker / See what attackers do

2. Security Features and Design
  • Establish a Framework for Major Security Control Projects
  • Establish Relevant Security Documents

3. Standards and Requirements
  • Establish the Standards and Requirement Documents Which Are Required by the Organization

Advantages of Onward Security

  1. Provide one-stop service from testing to document preparation.
  2. Provide a technical document, which can meet the European and American regulations and medical standards at the same time; and can use the provided technical document to establish the engineering and technical archives conforming to traceability and consistency.
  3. Not only provide FDA application documents and test reports but also assist customers to import cybersecurity requirements in the product development stage, so as to make long-term development planning for customers.


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Why Onward Security

In-depth Cybersecurity Techniques+

  • Uncovered 40+ zero-day vulnerabilities (CVE)
  • Discovered 3000+ IoT product vulnerabilities

Dedicated to IoT Product Security+

  • 200+ cybersecurity projects in IoT industry
  • Tested 1000+ IoT product security

Global Compliance and Certification Capability+

  • 500+ customers / 20+ countries certification obtained
  • Compliance experience in Automotive, Consumer, Industrial, and Medical industry
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