
ISO 13485:2003
International Standard specifies the quality system requirements for the design/development, production and, when relevant, installation and servicing of medical devices
CE Certificate
Council Directive 93/42/EEC, Annex II, Section 3.2. Medical Device Directive
FDA
PatLog 1.0 FDA cleared 1/23/2009 K090044
PatLog 2.0 FDA cleared 10/9/2009 K092939
ONCOlog Medical registered for sale in the Russian territory