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Cyber Security for 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: 

Our standards

ISO 14971

ISO 14971 was developed by the International Organization for Standardization (ISO).

ISO 14971 is a standard that provides guidelines for the risk management of medical devices. It includes requirements for managing cybersecurity risks in medical devices.

IEC 62304

IEC 62304 is a standard from the International Electrotechnical Commission (IEC) that provides guidelines for software lifecycle processes in the development of medical devices. It also includes requirements for managing cybersecurity risks in medical software.

EU MDR and FDA Guidelines

Ensuring regulatory compliance according to e.g. European (MDR) and US regulations (FDA) for medical device manufacturers. They require to identify and address cybersecurity risks at all stages of product development.

ISO 81001-5-1

The standard complements IEC 62304 by addressing important aspects of cybersecurity for software used in connected health technologies.

It provides a framework for the activities that must be carried out throughout the entire product lifecycle—from product development to use and ongoing monitoring—to protect against current and future cyber threats.

Security Process Description

Protected: Cyber Security ENG
Threat Modeling Secure Development Practices Vulnerability Management: Security Testing

Threat Modeling

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 Practices

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 that our software is robust and resilient against attacks.

Vulnerability Management:

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

Security Testing

We utilize 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 collaborates successfully with leading industry partners and is 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.