INTERNATIONAL MEDICAL SOLUTIONS

Our background in medical devices has required sustained engagement with hospital systems, clinical workflows, and physician teams. As a result, we possess a practical understanding of how care is delivered in China — not only in theory, but in day-to-day clinical operations, including specialist access, treatment coordination, and institutional processes.

Building on this foundation, we support international partners in evaluating and, where appropriate, developing China as a medical destination. Our role is not patient referral, marketing, or medical decision-making. Instead, we act as a local medical solutions partner, providing feasibility assessment, provider coordination, and on-the-ground support within clearly defined and compliant scopes.

We work with a strong emphasis on transparency, risk awareness, and realistic expectations, supporting structured collaboration models that align with international standards and partner compliance requirements.

Performance evaluation is a requirement in the In vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
It  refers to an assessment and analysis of data to establish or verify the  scientific validity, the analytical and, where applicable, the clinical  performance of a device.

To legally market an in vitro diagnostic medical device in the EU,  manufacturers must comply with the requirements outlined in the IVD  Regulation. This includes providing clinical evidence that supports the  intended use of the device, which should be based on an ongoing process  of performance evaluation.

Performance  evaluation shall demonstrate the scientific validity, analytical  performance and clinical performance of the device and it shall follow a  performance evaluation plan. The clinical evidence derived from the  performance evaluation shall provide scientifically valid assurance that  the relevant safety and performance requirements of the IVD Regulation  are fulfilled.