Quality Management

Qualification and validation for international markets

Singmed uses a globally standardized quality management system that is based on below standards.

EN ISO 13485 for Medical Devices

EN ISO 15378 for Pharmaceutical Primary Packaging

US FDA DMF

China NMPA Pharmaceutical Primary Packaging DMFs

China NMPA Medical Instrument Registration

Qualification and Validation for international markets

Comply with the relevant US FDA guidelines

Clean room area in accordance with ISO 14644-1 ISO classes 7 and 8, or respectively GMP classes C and D.

Incorporate risk management, batch/lot traceability, validation of critical processes, and environmental control

Comply with legal, regulatory, and pharmaceutical industry requirements