Analisi e gestione dei rischi per i dispositivi medici. Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title 21 cfr part 11 duration. In accordance with adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on. This white paper is designed to clear up any misunderstandings regarding documents required by this standard, as well as outlining nonmandatory documents that are commonly used. Medical devices application of risk management to medical.
Pdf iso 14971medical device risk management standard. Iso 14971 medical devices application of risk management to medical devices is an iso standard for the application of risk management to medical devices. Iso 14971 is an iso standard for the application of risk management to medical devices. Bsi training solutions is your premier training service provider for management systems. Building information modelling bim business continuity iso 22301.
In accordance with adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. This standard is the culmination of the work starting in isoiec guide 51, and isoiec guide 63. Iso 14971 defines risk analysis as a systematic use of available information to identify hazard s and to. May 27, 20 compliance with medical standards iec 62304, iso 14971, iec 60601, fda title 21 cfr part 11 duration.