Simplimedica has extensive experience in Medical Device Software (EN 62304). We have managed CE Technical File, UKCA and FDA submissions for software that is predictive, monitoring solutions, diagnosing, and more. Many of our case studies are with start-up solutions that have no idea of the regulatory complications involved in legalising their device for commercial use. With our experience we can advise the best pathway to conformity and very often with less complex solutions to get your Medical Device Software classified and certified. We have dealt with Class I, II and III devices as well as IIa and IIb for UKCA/CE as well.

In today’s digital landscape, medical software and device companies face unprecedented cybersecurity challenges. With increasing regulatory scrutiny, evolving cyber threats, and the critical nature of patient data, compliance is no longer optional—it is essential. Our Cybersecurity Compliance Service ensures your company meets the highest security standards while maintaining regulatory compliance, mitigating risks, and fostering stakeholder trust.

Why Cybersecurity Compliance Matters in the Medical Sector

Medical devices and healthcare software are prime targets for cyber threats due to the sensitive nature of patient information and the critical role these systems play in healthcare delivery. A cybersecurity breach could lead to:

• Patient Safety Risks – Hacked or malfunctioning devices can lead to incorrect diagnoses or life-threatening failures.
• Data Breaches – The exposure of protected health information (PHI) can lead to legal, financial, and reputational damage.
• Regulatory Non-Compliance – Failure to comply with FDA, MDR, ISO 27001, HIPAA, and NIST standards can result in hefty fines, product recalls, and loss of market access.

Our Cybersecurity Compliance Service

We provide end-to-end cybersecurity compliance solutions designed specifically for medical device manufacturers and healthcare software providers. Our service includes:

1. Risk Assessment & Gap Analysis

• Comprehensive cyber risk assessments to identify vulnerabilities in medical software and devices.
• Regulatory gap analysis to evaluate compliance with ISO 13485, ISO 27001, IEC 62304, FDA Cybersecurity Guidance, MDR, HIPAA, and NIST CSF.

2. Security Architecture & Design Compliance

• Implementation of secure software development life cycle (SDLC) practices.
• Threat modelling and penetration testing to identify and mitigate security flaws in device connectivity, cloud applications, and embedded systems.

3. Regulatory Compliance Support & Documentation

• Assistance in preparing FDA 510(k) cybersecurity submissions, MDR technical documentation, and compliance reports.
• Development of Software Bill of Materials (SBOM) in line with FDA and EU MDR requirements for supply chain transparency.

4. Incident Response & Threat Management

• Proactive monitoring, threat detection, and real-time security alerts.
• Creation and testing of incident response plans to minimize downtime and regulatory penalties.

5. Training & Awareness

• Customized cybersecurity training for R&D, quality, and regulatory teams.
• Simulation of phishing attacks, ransomware scenarios, and cybersecurity drills.
• Secure Your Medical Software & Devices Today

Let us help you achieve cybersecurity compliance with confidence. Contact us today to safeguard your products, protect patient data, and maintain regulatory compliance in a rapidly evolving healthcare landscape.

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Below are just some examples of our clients in this sector: