QUALITY MANAGEMENT SYSTEM DEVELOPMENT
SIC can provide practical and efficient SOPs for:
- ISO 13485:2016
- MDSAP
- Thai GMP for Medical Devices, Good Distribution Practice for Medical Devices (GDPMD)
- Medical Device Directive (93/42/EEC) – CE Marking
- In-Vitro Diagnostic Medical Device Directive (98/79/EC) – CE Marking
- EU Medical Device Regulation (MDR 2017/745)
- US Quality System Regulation (21 CFR Part 820)
- Japan Quality Management System (J-QMS Ordinance)