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 the European Medical Devices Directive 93/42/EEC, and U.S. FDA Quality System Regulations, 21CFR Part 820.
NeoMed has received market authorization from the U.S. FDA, Health Canada, the European Union, and the Therapeutics Goods Administration of Australia.
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BSI ISO 13485:2003 Certificate # FM 553493
BSI CE Certificate #569269
Health Canada Device License # 82410, 82411, 82412, 82413, 82414, 82415, 82416, 88404
USA FDA Cleared 510(k) Numbers: K072997, K073596, K081515, K082238, K092908, K100288, K072881, K120182, K122373, K120182, K143344, K152857