Professional Consulting Thrives Your Success

With extensive industry experience, we help clients bring medical products to market efficiently and compliantly.

We provide professional consulting including FDA 510(k) Clearance, CE MDR Certification, NMPA domestic and import registration, and NMPA innovative medical device application.

We draft NMPA equivalent device clinical evaluation reports and CE clinical evaluation reports, and provide support for clinical trial quality control and clinical audit.

We provide Quality Management System (QMS) consulting, covering ISO 13485:2016, FDA QSR 820, and NMPA registration & manufacturing quality system inspection.