As healthcare technology evolves, medtech cyber security has become critical. From regulatory compliance to patient safety, the stakes are high. At Amicis Group, we help medical device manufacturers secure their products, meet international standards and build trust with healthcare partners and regulators alike. In this article we discuss the issues around protecting medical devices, ways of ensuring better outcomes and some of the compliance standards to consider.
Protecting Innovation, Patients and Compliance of MedTech
Amicis Group works with innovative companies of all sizes, from early-stage start-ups to established providers, offering expert guidance, hands-on technical services and long-term support tailored to your needs. We have close relationships with those in the medical arena and have developed significant experience in the sector. Feel free to contact us to discuss how we ay be of help with your product, whatever the stage of development.
Why Cyber Security Matters in Medical Technology
Connected medical devices can be vulnerable to cyber threats that affect safety, performance and data privacy. Whether you are preparing for a product launch, submitting to the Medicines and Healthcare products Regulatory Agency (MHRA) or Food and Drug Administration (FDA), or already operating in the market, you need to demonstrate that your product is secure, reliable and compliant.
We help you:
- Address risks across software, firmware, mobile apps and cloud services
- Meet global standards including EU MDR, UKCA, IEC 60601 and FDA guidance (including FDA 510(k) see below)
- Strengthen your technical file with evidence-based assessments
- Reduce business risk, protect patients and support faster approvals
Medical Device Cyber Security – Our Offerings
We have a variety of offerings that we put on the table for consideration for cyber security services for medical devices and are happy to discuss with you which is likely to be most beneficial. These include
Penetration Testing for Medical Technology Devices
Our CREST methodology penetration testers simulate real-world cyber-attacks to uncover security weaknesses across your product ecosystem. This includes:
- Wireless and protocol security including Bluetooth and Wi-Fi
- Embedded software and firmware analysis
- Mobile app and cloud service testing
- Authentication and data access reviews
- Threat modelling and risk prioritisation
Every engagement ends with a clear, regulator-ready report including evidence, risk ratings and recommended actions.
Security Compliance Support
From initial development through to post-market surveillance, we help you understand and meet regulatory cyber requirements. Our team works alongside yours to interpret and implement guidance from:
- European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR)
- Food and Drug Administration (FDA) premarket and post-market guidance
- UK Conformity Assessed (UKCA) marking requirements
- IEC 60601 and related standards
We support documentation, gap analysis, and risk mitigation planning to ease your route to market.
Managed Security Services
For scale-ups and enterprises, we offer managed services to embed security into your business without slowing your growth. These services can include:
- Ongoing vulnerability management and testing
- Secure software development guidance
- Internal audit support and technical file development
- Regular check-ins with your product and compliance teams
This allows your teams to focus on innovation while we take care of the cyber risks.
Supporting FDA 510(k) Cybersecurity Compliance
Entering the US market requires a clear strategy for FDA 510(k) submissions. We support medical device companies by embedding cybersecurity best practice throughout the process, ensuring your submission meets regulatory expectations with confidence.
Key Steps to a Successful Submission of FDA 510(k)
Find a Predicate Device
Identify an existing, legally marketed device to demonstrate substantial equivalence.
Build Quality Processes
Implement a strong quality management system to align with FDA expectations on device safety and cybersecurity.
Test Thoroughly
Conduct robust testing to validate product safety, performance and resilience.
Prepare Your Submission
Compile your 510(k) file with clear device information, cybersecurity evidence and a comparison with the predicate.
Five Tips for Better Outcomes with Medical Device Cyber Security
- Start planning early to avoid delays
- Stay in touch with the FDA throughout
- Keep documentation clear and complete
- Follow the latest guidance and updates
- Partner with experienced regulatory consultants
About Amicis Group
Amicis Group is a UK-based cyber security partner with a specialist focus on regulated industries. We bring together decades of experience in cyber security with first-hand knowledge of the healthcare landscape. Our team includes experts with backgrounds in clinical care, NHS commissioning and NICE guidelines, giving us a unique perspective on the challenges faced by medical device innovators.
This blend of technical and medical expertise allows us to deliver practical, compliance-focused security solutions that make sense in real clinical environments. We understand how to align cyber risk management with safety, regulatory and commercial objectives, so you can move forward with confidence.
Who We Work With
Our clients include digital health pioneers, connected device manufacturers and healthcare scale-ups across the UK and Europe. We understand the pressure of clinical environments and regulatory frameworks and we aim to make security a business enabler, not a barrier.
Whether you are preparing your first submission or scaling globally, we can support you.
Our Partnership Approach
We do not offer one-size-fits-all services. We work in partnership with our clients, building long-term relationships that evolve as your product matures. You can rely on us for transparent advice, expert delivery and an approach grounded in real-world healthcare knowledge.
Conclusion – MedTech Cyber Security. Your next steps.
Every medical device is different. That is why we start by listening.
Feel free to to call us today on 0333 305 5348 or use our Contact Us page and we will take the time to understand where you are on your journey and what support you need. Whether it is a single penetration test or ongoing compliance guidance, we are here to help. See our Medical Device Cyber Security Page for more information
You may also be interested in our Navigating FDA 510(k) Cyber Security for Medical Devices post and our update post FDA 510(k) Update for MedTech: What Businesses Need to Know in 2025.
