FDA-CYBERSECURITY › Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
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2017/745REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
BS-EN-ISO-15223-1
Medical devices. Symbols to be used with information to be supplied by the manufacturer
BS-EN-ISO-13485
Medical devices. Quality management systems. Requirements for regulatory purposes
Document Number
FDA-CYBERSECURITY
Revision Level
2023 EDITION
Status
Current
Publication Date
Sept. 27, 2023
Page Count
57 pages