Rui Enni helps a company in Jiangsu obtain the CE MDR certification for nutrition pipelines!
Overcoming difficulties and working together to break through:
CE MDR is the latest regulation issued by the European Union for medical devices, with clinical safety, technical compliance, and full lifecycle supervision as the core. The certification standards are strict and the process is complex. To assist enterprises in efficiently completing certification, our company has formed a professional team to provide full process consulting services, including product clinical evaluation, CE technical document optimization, and quality management system upgrade (adding MDR QMS).
Accurate benchmarking of regulations: Assist enterprises in organizing MDR technical documents, improving risk management (ISO 14971), usability engineering (IEC 62366&IEC60601-1-6), and clinical evaluation evidence;
Rapid response and rectification: Provide data supplementation and compliance strategy support for technical questions raised by the notified body (SGS1639);
Milestone significance
The passing of this certification not only demonstrates the technological leadership and international market competitiveness of the enterprise's products, but also sets a benchmark for China's medical device industry to break through the EU's technical barriers. In the future, this series of products will serve European medical institutions, benefit patients worldwide, and lay a solid foundation for enterprises to expand overseas markets.
