OBELIS

As the regulatory partner of the TEN4CARE project, OBELIS plays a key role in ensuring that innovative healthcare solutions can successfully reach the European market in compliance with strict EU regulatory requirements. Our experts work to clearly define the device/substance intended use, establish the correct qualification and classification, and design a tailored regulatory strategy to support future applications. We guide partners in preparing and managing the technical documentation required for regulatory submissions, while also assessing the impact of any design or claim changes that may arise during the project.

To keep the consortium aligned with the latest developments, OBELIS closely monitors evolving regulations and standards from bodies such as the Medical Device Coordination Group (MDCG), EMA, and ICH, providing timely recommendations to maintain compliance. This proactive approach ensures that TEN4CARE innovations are supported by a robust regulatory foundation, paving the way for safe and effective market access.