Regulatory Affairs for Medical Devices & IVDs (EU MDR & IVDR)

D.med Technologies provides end-to-end Regulatory Affairs expertise for medical device and IVD manufacturers, research organisations, and Horizon Europe consortia. We support partners throughout the entire product lifecycle, ensuring regulatory requirements are integrated early and efficiently into research, development, and commercialization activities.

Our services cover EU MDR (2017/745) and IVDR (2017/746) regulatory strategy, device classification, conformity assessment planning, and interaction with Notified Bodies. We prepare and maintain regulatory-compliant technical documentation, including GSPR, device descriptions, benefit-risk analysis, software documentation, labeling, and submission-ready dossiers.

We also support the implementation and optimization of ISO 13485 Quality Management Systems, ISO 14971 risk management, and clinical and performance evaluation activities (CEP/CER, PEP/PER), ensuring alignment with regulatory expectations and project objectives. Our pragmatic and scalable approach is particularly suited to SMEs, startups, and research-driven projects aiming to progress from R&D to CE marking.

D.med Technologies has extensive experience collaborating in EU-funded and multi-partner projects, helping translate innovative medical technologies into compliant, market-ready solutions while reducing regulatory risk and time to market.

Ideal cooperation partners:

• Horizon Europe / Cluster Health consortia

• Medical device and IVD manufacturers

• Research institutes preparing clinical validation or market translation

• SMEs and startups requiring regulatory strategy and execution support