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October shines a spotlight on cybersecurity and for medical device manufacturers, the stakes couldn’t be higher. From clinical safety to regulatory compliance and patient trust, every layer of your system needs protection.
At Promenade Software, we created CypherMed Cloud to give your development teams a secure, compliant, and developer-friendly platform that speeds up releases without compromising safety.
CypherMed Cloud was developed to meet the real-world needs of our clients. We wanted to create a system that doesn’t just meet regulatory requirements, but makes them part of the workflow from the very start.The result is a system that embeds medical-grade security and lifecycle controls from day one, instead of retrofitting security and controls later.
The platform helps you stay on top of risk assessment for your device class, while being grounded in trusted standards: it’s built on an ISO 13485 certified framework and holds SOC 2 Type 2 certification. It’s a complete, reliable solution designed to make medical device development faster and safer.
Our security approach is structured in four reinforcing layers—from certified governance down to cryptographically isolated data—all aligned with FDA pre- and post-market expectations.
The Outer Layer: Certified Compliance
This is your first line of confidence. With SOC 2 Type 2, HIPAA, and GDPR compliance, plus FDA cybersecurity documentation included, you know that your system meets the highest recognized standards. It’s like having a trusted seal on the front door of your medical device ecosystem.
Layer 3: Continual Threat Monitoring
Beyond compliance, we actively watch for threats. Ongoing vulnerability monitoring, enterprise-grade intrusion detection and prevention systems (IDS/IPS), and both automated and external penetration testing help catch issues before they become problems. Think of it as a 24/7 security guard for your system.
Layer 2: Access Control
This layer puts you in the driver’s seat. User roles and granular permissions ensure the right people have the right access. Complete transaction logs give full traceability and accountability, and contingency plans keep your operations running smoothly, so every action across your device fleet is tracked and secure.
The Core: Secure Data Architecture
At the heart of it all is your most valuable asset: the data. Cryptographically isolated data groups, end-to-end encryption, and secure authentication protect your information at every connection point. Secure user and device management ensures that what’s inside the core stays safe and under control.
CypherMed Cloud helps your developers build and deliver features more efficiently, without ever compromising security or quality. Our OpenAPI framework and SDKs allow engineers to focus on creating great software while the platform automatically enforces the right security defaults.
In Practice, That Means:
CypherMed Cloud keeps medical devices and their data safe, secure, and reliable. Built-in tools and workflows make development easier while providing strong access controls, and easy data collection. It’s a platform designed to help medical device development teams work confidently and efficiently.
As you plan your 2026 roadmap, it’s important to ensure your cybersecurity strategy aligns with regulatory requirements and patient safety objectives. If you need guidance navigating these requirements or assessing your risks, our team is available to help.
