Macular Degeneration – MEAVISTA ProgramISO 9001:2008
Quality ManagementISO/IEC 90003:2004 ComplianceISO 9004:2009 ComplianceISO/TS 16949:2009Software EngineeringKit of Checklists of FDA Requirements for Medical Devices (PDF)IEC 60601 Medical Electrical EquipmentANSI/AAMI/ISO 13485:2003 - Medical Devices, RequirementsANSI/UL 1998:2004 Compliance GuideISO/IEC 15288:2008 ComplianceISO/IEC 20000-1:2011 Information TechnologyFDA 21 CFR Compliance RequirementsFDA Software ValidationISO/IEC 27002:2005 Security TechniquesIEC 62304:2006 Checklist Software Life Cycle ProcessesTemplates for Software and System ManagementFDA Off-the-Shelf Software in Medical DevicesPre-market Submissions of Software in Medical DevicesGuides to
Software Engineering
StandardsReference

Publishing Translations Consulting