IEC 81001-5-1 – Cybersecurity Consulting for Medical Devices (SaMD/MDSW and IVD)

Ensure Cybersecurity Compliance and Risk Management for Medical Devices

At QMLogic, we offer expert cybersecurity consulting services specifically tailored for manufacturers and developers of medical device software (SaMD/MDSW) and software-based in-vitro diagnostic. Our services ensure compliance with IEC 81001-5-1, FDA cybersecurity guidance, and EU MDR/IVDR requirements. We integrate cybersecurity risk management directly into your product life cycle, technical documentation, providing a seamless, practical design controls to regulatory expectations.

Our Cybersecurity Consulting Services for IEC 81001-5-1 Compliance

Implementation of IEC 81001-5-1 Across the Entire Product Life Cycle
Practical support to ensure cybersecurity compliance from initial planning to post-market monitoring.
Alignment with Risk Management, Design Controls, and Software Architecture
Logical integration of cybersecurity risk analysis with your existing ISO 14971 risk management file and software design documentation.
Development of a Complete Cybersecurity File
Preparation of the required cybersecurity file that supports CE Marking, FDA submission, and MDSAP audits.
Threat/Risk Analysis for Medical Device Software
Conducting structured threat modeling and risk assessment to address vulnerabilities specific to medical devices and connected healthcare systems.
Cybersecurity in Software Development Activities
Hands-on guidance and cybersecurity consulting services during:

Software Development Planning
Requirements Analysis
Software Architectural Design
Software Verification & Validation
Software Release and Maintenance including vulnerability scanning

Who Needs to Comply with IEC 81001-5-1?

IEC 81001-5-1 compliance applies to:

Implementation of IEC 81001-5-1 Across the Entire Product Life Cycle
Practical support to ensure cybersecurity compliance from initial planning to post-market monitoring.
Alignment with Risk Management, Design Controls, and Software Architecture
Logical integration of cybersecurity risk analysis with your existing ISO 14971 risk management file and software design documentation.
Development of a Complete Cybersecurity File
Preparation of the required cybersecurity file that supports CE Marking, FDA submission, and MDSAP audits.
Threat/Risk Analysis for Medical Device Software
Conducting structured threat modeling and risk assessment to address vulnerabilities specific to medical devices and connected healthcare systems.
Cybersecurity in Software Development Activities
Hands-on guidance and cybersecurity consulting services during:

Software Development Planning
Requirements Analysis
Software Architectural Design
Software Verification & Validation
Software Release and Maintenance including vulnerability scanning

Organizations operating under EU MDR/IVDR, FDA cybersecurity guidance, or international standards must implement robust cybersecurity measures to safeguard patient safety, data integrity, and device performance. IEC 81001-5-1 consulting services ensure your software meets these requirements and reduces the risk of cybersecurity-related non-compliance or harm.

Why Work With QMLogic for Cybersecurity Consulting Services?

Proven Regulatory and Cybersecurity Expertise
We combine regulatory compliance knowledge with technical cybersecurity consulting, ensuring practical solutions for software development teams.
End-to-End IEC 81001-5-1 Implementation
From software architecture to threat/risk analysis, we handle the entire cybersecurity risk management process, ensuring a clear path to regulatory approval.
Integration with ISO 14971 and IEC 62304 Standards
Our consulting services bridge cybersecurity requirements with existing risk management (ISO 14971) and software lifecycle processes (IEC 62304).Preparation of cybersecurity documentation for regulatory submissions in Europe, the U.S., and other jurisdictions.

Related Cybersecurity Compliance Services

Looking for more? Learn about our related services for:ISO 14971 Risk ManagementSee more IEC 62304 Software Lifecycle ProcessesSee more QMS Software Implementation & Automation ToolsSee more

Testimonials | Our Expertise in MedTech

Ypsomed

Dilli Ramannagari

Risk Manager | Cybersecurity

Vaclav and I worked together on risk management activities of medical device development projects. His ability to quickly grasp the challenges and to accomplish a task/project is remarkable. Additionally, his ability to propose and develop software solutions to improve projects’ efficiency is commendable. I find Vaclav to be flexible, dependable, and quality centric. Hence, I really enjoyed working with Vaclav and looking forward to associate with him again.

Dentsply Sirona

Pascal Resin

Chapter Lead and Manager Scrum Masters

I had the pleasure to work with Vaclav on Software as Medical Device processes topics, and can only recommend him! It is not only that he has a very high and reliable knowledge in the medical domain, the regulatory domain and the software one, but also that whatever he approaches, he does it in a reasonable and clever way, taking into account the big picture and the real expectations from authorities and the goals of the organisation. With a good internal sponsor to support him, he delivers on his promises very efficiently, and collaborates in a great way, relying on his very good communication skills!

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