Medical Device Cyber Security

Secure Medical Devices Throughout the Product Lifecycle

Medical device cyber security is now a critical component of patient safety, regulatory compliance and product success.

As medical devices become increasingly connected, manufacturers must demonstrate that cyber risks have been identified, managed and monitored throughout the product lifecycle. This is also a key component of the FDA 501(k) pre-market submission.

Amicis Group helps medical device manufacturers, digital health innovators and healthcare technology providers develop secure, resilient and compliant products from design through to post market operation.

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Why Medical Device Cyber Security Matters

Modern medical devices rely on software, connectivity and data exchange.

Cyber vulnerabilities can impact:

Regulators increasingly expect manufacturers to demonstrate that cyber security has been considered throughout product development and operation.

Why Organisations Choose

Our goal is to help organisations build trust with regulators, healthcare providers and patients while reducing cyber risk.

Our Medical Device Cyber Security Services

We support organisations with:

Security assessments and gap analysis
Secure by design guidance
Medical device penetration testing
Vulnerability management
Regulatory readiness support
Security governance and documentation
Post market cyber security planning

Our approach balances innovation, compliance and patient safety.

Regulatory and Compliance Support

Medical device cyber security requirements continue to evolve across the UK, Europe and the United States.

Amicis Group helps organisations align with:
FDA cyber security expectations
EU MDR requirements
UK regulatory guidance
FDA 510(k) submission support
Risk management frameworks
Post market surveillance obligations

We help organisations demonstrate security controls while preparing for regulatory review and procurement requirements.

Frequently Asked Questions

What is medical device cyber security?

Medical device cyber security refers to the protection of connected medical technologies, supporting software and associated infrastructure from cyber threats that could compromise patient safety, data integrity or system availability.

Why is cyber security important for medical devices?

Cyber security vulnerabilities can affect patient safety, operational continuity, regulatory compliance and commercial adoption. Regulators increasingly expect cyber security to be embedded throughout the device lifecycle.

What is secure by design?

Secure by design is the practice of incorporating cyber security controls into products from the earliest stages of development rather than attempting to add them later.

How does penetration testing support compliance?

Penetration testing helps identify exploitable vulnerabilities, validate security controls and provide evidence that cyber risks have been assessed and addressed appropriately.

What are post market cyber security responsibilities?

Manufacturers are increasingly expected to monitor vulnerabilities, manage security updates, maintain incident response processes and reassess cyber risks throughout the operational life of a device.