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REGULATORY
Third-party CE marking service
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What do we offer?
We offer our regulatory department as a strategic partner to accelerate your medical software’s access to the EU market.
We make our Regulatory Department available to third parties. We act as your strategic partner to navigate legal complexity, ensuring that your AI-powered Software Medical Device obtains CE marking as a requirement for commercialization.
Our offering is structured around three fundamental compliance pillars:
AEMPS License and Management in Spain
To operate legally in the Spanish market, the first step is administrative authorization of your facilities and processes under Royal Decree 192/2023.
Prior Operating License: We fully manage obtaining your license as a manufacturer or importer before the Spanish Agency of Medicines and Medical Devices (AEMPS).
Technical documentation
We prepare technical documentation according to Regulation (EU) 2017/745 (MDR) requirements, tailored to the reality of modern software medical devices, with special focus on algorithm validation.
AI Training and Lifecycle: We prepare documentation for model training, validation and testing processes, aligning your software with the EU’s new Artificial Intelligence Regulation.
Clinical Validation: We design clinical evaluation plans to confirm the software’s safety and clinical benefit.
Strategic Classification (Rule 11): We precisely determine the risk class based on the clinical outcome’s impact and the severity of the medical situation.
ISO 13485 Quality
We implement ISO 13485 quality management systems applicable to medical devices, in compliance with applicable regulatory requirements.
We are not a conventional external consultancy; we are innovation-leading manufacturers who apply these same processes daily in our own cutting-edge developments.
