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Cyber Security in Medical Products

Cyber Security

In the increasingly interconnected and digitized healthcare industry, users and manufacturers face significant challenges. The expanding attack surface and growing system complexity require a structured approach to cybersecurity. A systematic approach is crucial to meet the rising demands for the security of medical products. 

To meet these demands, we at Softgate GmbH ensure our cybersecurity measures adhere to current standards: 

NIST SP 800-53
NIST SP 800-53
NIST SP 800-53
NIST SP 800-53
IEC 62304
IEC 62304

IEC 62304 is a standard created by the International Electrotechnical Commission (IEC) to provide guidelines for software life cycle processes in the development of medical devices. Within this standard, there are also requirements for managing cybersecurity risks in medical software.
ISO 14971
ISO 14971
ISO 14971 was developed by the International Organization for Standardization (ISO). ISO 14971 is a standard that provides guidelines for risk management of medical devices. It includes requirements for managing cybersecurity risks in medical devices.
ISO 81001
ISO 81001
Integrating cybersecurity throughout the entire lifecycle of medical products.
FDA- Leitlinie der Markteinführung
FDA Market Introduction Guideline

The U.S. Food and Drug Administration (FDA) provides guidelines for manufacturers of medical devices. The guidelines include recommendations for managing cybersecurity risks in medical devices. The guidance assists manufacturers in integrating cybersecurity controls throughout the entire product life cycle, including during the design, development, and maintenance phases.
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Slide 1-4 : IEC 62304,  ISO 14971, ISO 81001 and EU MDR and FDA Guidelines:

Security Processdiscribtion

Integrated safety from the initial idea to implementation

Threat modelling

Using the ANSI/AAMI SW96:2023 standard, we systematically identify and address potential threats during the design phase. This involves a structured approach to risk assessment and management to ensure comprehensive security coverage throughout the product lifecycle.

Secure Development

We emphasize adherence to proven security principles throughout the development process, including “Least Privilege,” “Defense in Depth,” and “Security by Design.” Our stringent coding practices minimize vulnerabilities and ensure our software is robust and resilient against attacks.

Vulnerability management

Conducting continuous monitoring and regular security scans to quickly identify and address potential threats, keeping systems secure and compliant.

Secure testing

Utilizing techniques such as static and dynamic analysis, as well as advanced security testing, to evaluate and enhance the implementation of security requirements in our products.

Our expertise

With many years of experience in cybersecurity for medical products, our team has successfully collaborated with leading industry partners and been involved in all process steps—from initial planning and development to risk management, implementation, and continuous monitoring. Below are some examples of our successful projects.

Creating a Threat and Risk Analysis
We developed a comprehensive threat and risk analysis for an integration platform deployed within the operating room. Utilizing the STRIDE model, we systematically identified Cyber Security risks and subsequently derived…
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Support during complete SDLC
We assisted in implementing a Software Development Life Cycle (SDLC) as an integral component of a new product platform for a prominent medical device manufacturer. This encompassed conducting threat and…
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SBOM based vulnerability analysis
We created a Software Bill of Materials (SW SBOM) and gathered information regarding existing vulnerabilities. In partnership with the customer, we conducted a thorough analysis of the available data, leading…
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More Use Cases

Niko Assmann

Sales Consultant

Contact us:

Please feel free to reach out to my team and me if you have any questions. We would be happy to give you an initial overview of how you can achieve your individual goals with our efficient solutions.