May 7-8, 2025 – Tiankang invited Mr. Ke (General Manager) and Mr. Ran (Project Manager) from Intertek Group as technical consultants for specialized guidance on MDR CE certification. This collaboration marks a critical step in the company’s international compliance efforts for medical devices, laying a solid foundation for entering the EU market.

The EU Medical Device Regulation (MDR) is one of the most stringent regulatory frameworks in the global medical device industry, emphasizing "higher safety and comprehensive traceability." It systematically regulates clinical evaluation, technical documentation, quality management, and other key processes. Obtaining MDR CE certification is not only a mandatory requirement for accessing the EU market but also an international recognition of a company’s technical capabilities and quality management standards.

As a world-leading quality and safety service provider, Intertek possesses extensive expertise in medical device certification. During their visit, Mr. Ke and Mr. Ran delivered comprehensive technical guidance, covering MDR interpretation, technical documentation preparation, clinical evaluation strategies, and more, helping Tiankang accurately grasp certification requirements and mitigate compliance risks.

Over the two-day consultation, both parties engaged in thorough discussions on critical aspects of MDR certification:

1. Technical Documentation Optimization: Experts provided structured improvement suggestions for design documents, risk management reports, and validation data, emphasizing the integrity of "traceability" and "scientific evidence chains."

2. Clinical Evaluation Pathways: Tailored compliance solutions were analyzed, including equivalent device comparisons, literature reviews, and clinical data assessments based on product characteristics.

Key personnel from R&D, Quality Assurance, and Regulatory Affairs departments participated throughout the session. Through case studies and hands-on exercises, the team significantly enhanced its understanding and application of complex MDR clauses.

Tiankang’s Management Representative stated during the closing meeting: "MDR certification is a pivotal milestone in our globalization strategy. Intertek’s expert guidance has clarified our technical roadmap. Next, we will establish a dedicated task force to implement a ‘layered accountability and closed-loop improvement’ mechanism, ensuring efficient progress in certification preparations."

Moving forward, the company will leverage MDR CE certification as an opportunity to further integrate ISO 13485 with EU quality management requirements. By adopting digital tools to strengthen full lifecycle product management, Tiankang laims to develop medical device solutions that combine international competitiveness with patient safety assurance.

This consultation was not only a professional knowledge transfer but also a reflection of Tiankang’s unwavering commitment to "Quality Without Borders." In the wave of global healthcare innovation, the company will continue to drive advancements through high-standard quality management systems, delivering cutting-edge medical products to patients worldwide and fulfilling its mission as a leader in "Innovated-in-China" excellence.