Services

LEADING BRAND IN SECURITY ASSESSMENT - ONWARD

Compliance & Assessment Services

FDA Security Compliance Solution

Why Medical Cybersecurity?

Assist Customers to Produce Relevant Documents that Meet FDA Requirements

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

 

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

 

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 product development stage, so as to make long-term development planning for customers.