GaleMed has been actively involved in developing, manufacturing and marketing respiratory care products. Our success begins with our ability to apply our innovative ideals in combination with our technology to an endless array of customer needs.
- Quality System
ISO 13485: 2003 & 9001: 2008
FDA QSM
CMDCAS 13485: 2003
Japan J-GMP
Taiwan GMP
- Product Certification
CE Certificate
FDA Listing and 510(K)
Canada Registration for Medical device
Japan PMDA for Medical device
Mainland China Registration for Medical device
Taiwan Registration for Medical device
- Awards and Recognition
Taiwan SME Innovation Award for Sil.Flex™ Stoma Pad
Taiwan Industrial Innovation Achievement Award for nVCM Resuscitator
Taiwan Healthcare Industry Innovation and Excellence Silver Award
National Small and Medium Enterprise Award
National Rising Star Award
Golden Merchant Award
National Biomedical Quality Award
Taiwan Excellent Product Award for MR-100TM Manual Resuscitator
Taiwan Excellent Product Award for CPR-Super Pocket Mask
