En 606011 2007 risikomanagementprozess bei megeraten oder mesystemen es muss ein risikomanagementprozess nach iso 14971 durchgefuhrt werden. Richtlinie uber medizinprodukte, klasse im messend, is steril, iia, iib, iii egkonformitatserklarung. Seminar iso 14971 risiko management seminar medizinprodukte. Dieser aufbau ist effizient, weil mit geringem aufwand medizinpro. Report on risks and opportunities merck annual report 2014. Identity and access management iam business continuity management system bcms isms according to isoiec 27001.
A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Risikomanagement nach norm din en iso 14971 risikoanalyse. Pdf on may 4, 2018, reinhard strametz and others published. Risks and opportunities are inherent to entrepreneurial activity.
In dieser diplomarbeit wird ein risikomanagementsystem fur ein interkulturelles dezentrales. Iso 14971 makes an overview of the risk management process. Risikomanagementplan iso 14971 vorlage risikomanagement. Information rights management irm governance, risk and compliance. Risikomanagement fur medizinprodukte saqqualicon schweiz. All publications anforderungen an medizinprodukte risikomanagement advanced search. White paper verbesserung des risikomanagements fur. Merck has put systems and processes in place to identify risks at an early stage and to counteract them by taking appropriate action. Neuerungen im risikomanagement eine herausforderung fur. Lerm leitfaden risikomanagement fachhochschule kiel. Iso 14971 specifies a procedure for the manufacturer of a medical device or invitrodiagnostics. The standard is intended to be used as part of a quality system, but could be used where a quality system is not in place.
911 1198 1426 1084 236 1206 882 362 394 458 1111 859 1098 152 504 923 891 889 1216 1317 521 927 207 222 1110 1487 1289 360 161 935 1110 1189 780 1121 1292 692 1293 23 226 260 466 774 1142 589 1340