Qualification
Certification
- ISO 13485 Medical Equipment Quality Management System
- Standard (ISO 13485:2016)
- Excellent manufacturing of medical equipment(GMP 1375)
Global medical device licensing
- First-class medical equipment license from Taiwan's Ministry of Health Service
- U.S. Class I Medical Equipment Listing
- EU CE Class I medical device registration
- Vietnam Type A Medical Equipment License
Patents
- Polyurethane foam dressing patent
- Polyurethane gel dressing patent
- Liquid dressing patent