Certifications
ISO 9001:2015
Quality Management Systems
ISO 13485:2016
Medical Device Single Audit Program (MDSAP)
EN ISO 13485:2016
Medical Device - Quality Management Systems
Confirmation Letter for GMP Audit (Japan)
EC Certificate for Class Is & IIa
according to MDD 93/42/EEC
ISO 14001:2015
Environmental Management Systems
OHSAS 18001
Occupational Health and Safety Management Systems
NFPA 1999
UL Certification
ISEGA Food Contact
Test Certification (Germany)
National Medical Products Administration (NMPA)
National Fire Protection Association (NFPA) Member
FDA 510(k) Approval
PPE Notified Body
