The recent guidance on 21 CFR 11, the upcoming deadline for European CE Marking, and the needs of quality system regulation (QSR) have generated much discussion about approaches to software validation. In this article, a view of software validation by the design team of a QSR medical device ...
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□ 医疗机构中的再加工医疗器械:验证方法和标识Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling □ 医疗器械患者标识指南Guidanceon Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers □ 器械建议的标识要求Labeling requirements from Device Advice ■...
FDA. General Principles of Software Validation. Dosegljivo: http: //www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm085281.htm, 2002. [Dostopano 5. 8. 2016]. U.S. Department Of Health,HS Food,D Administration,... 被引量: 50发表: 2002年 Target Product Profile...
FDA Bayesian Statistics Guidance for Medical Device Clinical Trials-Application to Process ValidationConventional statistical approaches to clinical trials work, ... D Leblond - 《Journal of Validation Technology》 被引量: 0发表: 2010年 FDA Bayesian Statistics Guidance for Medical Device Clinical Trials-...
deviceasSTERlLE’isonlypermissiblewhenavalidatedsterilizationprocesshasbeenapplied.Requirementsfor validationandroutinecontrolofprocessesforthesterilizationofmedicaldevicesarespecifiedinENISO11135,ENISO 11137,EN15014160,EN15014937,EN1$017665·1,EN1$020857,EN15025424and1$022441. ...
device regulatory authorities of ASEAN member countries. Product registration applications for medical devices submitted to HSA must be prepared in the format set out in the ASEAN CSDT document. This guidance document must be read in conjunction with the ASEAN CSDT document, the GN-15 Guidance...
BSI has in-depth knowledge and experience of medical equipment certification standards around the globe and can provide advice and guidance.
Full documentation, including design document control, risk management files, design history files, device master records, and quality system guidance documents Technical support and documentation preparation for regulatory submission packages, including premarket approval documents and package filing support Cert...
Google Scholar US Food and Drug Administration: General principles of software validation; final guidance for industry and FDA staff. Technical report, Center for Devices and Radiological Health, January 2002. http://www.fda.gov/medicaldevices/deviceregulationandguidance Download references ...