Regulatory Information
NeoMed holds globally recognized ISO 13485:2003 certifications from the prestigious British Standards Institution (BSI). This certification includes the Standards Council of Canada (SCC) endorsement under Canadian Medical Device Conformity Assessment System (CMDCAS) scheme. In addition to ISO 13485:2003, the company quality system is established and maintained to comply with European Medical Device Directive 93/42/EEC, and U.S. FDA Quality System Regulations, 21CFR Part 820.
NeoMed has received market clearance from the U.S. FDA, Health Canada, and the European Union.
Click the following links to view each document as specified below.
BSI ISO 13485:2003 Certificate # FM 553493
BSI CE Certificate # 569269
Health Canada Device License # 82410, 82411, 82412, 82413, 82414, 82415, 82416
US FDA 510k # K072997, K073596, K081515, K082238, K092908, K100288, K072881
NeoMed holds globally recognized ISO 13485:2003 certifications from the prestigious British Standards Institution (BSI). This certification includes the Standards Council of Canada (SCC) endorsement under Canadian Medical Device Conformity Assessment System (CMDCAS) scheme. In addition to ISO 13485:2003, the company quality system is established and maintained to comply with European Medical Device Directive 93/42/EEC, and U.S. FDA Quality System Regulations, 21CFR Part 820.
NeoMed has received market clearance from the U.S. FDA, Health Canada, and the European Union.
Click the following links to view each document as specified below.
BSI ISO 13485:2003 Certificate # FM 553493
BSI CE Certificate # 569269
Health Canada Device License # 82410, 82411, 82412, 82413, 82414, 82415, 82416
US FDA 510k # K072997, K073596, K081515, K082238, K092908, K100288, K072881
