Medical Device Cyber Security is no longer just a technical consideration, it is now central to achieving regulatory approval and maintaining trust in connected healthcare systems.
At Amicis Group, we support medical technology companies at every stage of their cyber security journey, from initial assessment to ongoing managed protection. Whether you are submitting a device for FDA 510(k) approval or ensuring your systems stay compliant across the full product lifecycle, our service is designed to reduce risk, streamline compliance and support commercial success.
Tailored Support for Regulatory Compliance
Medical device companies face a growing list of cyber security obligations from regulators such as the FDA, EU MDR and HIPAA. The latest 2025 FDA guidance, which enforces Section 524B of the Food, Drug and Cosmetic Act, outlines new documentation requirements, vulnerability management plans and expectations for secure-by-design systems.
Our team understands these requirements in detail and works with you to embed the necessary processes, controls and documentation into your development and operations.
We help with:
- FDA 510(k) premarket submissions and gap assessments
- Vulnerability management plans and patch control procedures
- Software Bill of Materials (SBOM) implementation
- Full lifecycle cyber security support for regulated medical devices
- Penetration Testing
Penetration Testing for Medical Devices
As part of our approach to medical device cyber security, we provide specialist penetration testing designed for the MedTech environment. This supports regulatory compliance by demonstrating that your devices and supporting infrastructure can withstand real-world cyber threats.
Testing results are clearly documented and mapped against regulatory expectations, giving you evidence of effective controls and helping to reduce the risk of delays during approval.
A Cyber Security Framework Built for Medical Devices
We offer a comprehensive framework tailored to the unique challenges of medical devices and digital health systems. Our team includes experts in both cyber security and healthcare technology, ensuring practical recommendations that meet compliance standards without blocking innovation.
Whether you are building software-driven medical devices, wearables, or cloud-based patient management systems, we help you meet modern expectations of security, resilience and transparency.
Why Choose Amicis Group for Medical Device Cyber Security?
- Trusted expertise in regulated cyber security
- Framework aligned with FDA, HIPAA and EU MDR standards
- Clear guidance with hands-on implementation support
- Flexible services for startups, scale-ups and established manufacturers
- Penetration testing, documentation support and managed compliance
Get Cyber Security Support Today for your Medical Technology
Whether you need a one-off assessment or a managed solution, our medical device cyber security team is ready to help. From FDA 510(k) readiness to lifecycle protection, we make compliance easier and help you build trust with partners, regulators and end users.
Call us today on 0333 305 5348 or email hello@amicisgroup.co.uk to speak with an expert.
