Compliance
We support R&D teams in building regulatory-ready Technical Documentation by embedding international standards, risk management, verification, and cybersecurity compliance into the development process, ensuring devices meet the latest FDA and EU MDR requirements with confidence.
Our Services
Standards & Compliance Frameworks
We ensure your medical device development is aligned with internationally recognized standards, ensuring compliance and audit readiness:
ISO 13485 – integration of technical outputs into the Quality Management System (QMS).
IEC 62304 – embedded software lifecycle management, from requirements to maintenance.
IEC 60601-1 / IEC 60601-1-2 – electrical safety and electromagnetic compatibility (EMC).
IEC 60825 – laser safety and related system requirement
This approach ensures that all technical deliverables are structured, traceable, and fully compatible with regulatory expectations.
Risk Management
& Safety
We support the application of ISO 14971 risk management principles directly into your R&D process, embedding safety at every stage:
Identification and analysis of hazards at hardware, firmware, and system level.
Definition of risk control measures such as watchdogs, redundancy, and failsafe states.
Traceability linking risk analysis to design controls, verification, and validation evidence.
Preparation and delivery of complete risk management documentation, ready for inclusion in regulatory submissions.
We ensure that risks are not only addressed proactively during development but also fully documented to withstand regulatory scrutiny
Verification, Validation & Documentation
We deliver comprehensive verification and validation (V&V) for medical devices, ensuring robust testing and complete documentation:
Design and execution of unit, integration, and system-level test protocols with requirements traceability.
Use of HIL (Hardware-in-the-Loop) and SIL (Software-in-the-Loop) environments for early validation.
Preparation and delivery of Verification Reports and Validation Reports with full evidence for audits.
Direct contributions to regulatory submissions, including FDA 510(k) files, EU MDR Technical Documentation, and Notified Body assessments.
Cybersecurity
Technical File
We ensure that cybersecurity compliance is built into product development, so your medical device meets the latest regulatory requirements without surprises at submission.
Integration of cybersecurity risk management throughout the design process.
Alignment with key regulations and guidance, including:
FDA Premarket Cybersecurity Guidance (2023)
MDCG 2019-16 Guidance on Cybersecurity for Medical Devices
- AAMI TIR57:2016 — Principles for medical device security risk management
- AAMI TIR97:2022 — Postmarket cybersecurity management
- UL 2900-1 / UL 2900-2-1 — Software cybersecurity for network-connectable medical devices
Delivery of cybersecurity documentation — including risk assessments, threat models, and verification evidence — directly usable in Technical Files and regulatory submissions.
Our role is to give your R&D team confidence that the device is ready for the new cybersecurity expectations of FDA, EU MDR, and Notified Bodies, ensuring compliance and smooth market approval.
Discover Our Innovative Approach
At Caducia, we believe that innovation is the driving force behind success. Our team of experts is ready to transform your ideas into tangible solutions. Get in touch with us to explore how we can collaborate on your most ambitious projects.
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