Service

•  Coaching on complying with the registrant system by the MAH

•  ISO 13485 and ISO 9001 certification guidance

•  Full lifecycle quality system service

•  GMP workshop design coaching and on-site audit

•  Product production and quality control under the GMP environment

•  Internal audit/the third-party audit of domestic and foreign quality systems

•  Computer information management system

•  Risk management guidance: Registration for marketing and continued study after marketing

•  Post-marketing Periodic Safety Update Reports (PSUR): AE monitoring reports for medical devices sold in China and summary report of foreign AEs of medical devices.

•  Suspected unexpected serious adverse reaction (SUSAR) report