Why Medical Cybersecurity?
Assist Customers to Produce Relevant Documents that Meet FDA Requirements
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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
- Provide one-stop service from testing to document preparation.
- 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.
- 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.
