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What do you need for cybersecurity risk management?

The four most common root causes for any quality issue are 1) inadequate procedures, 2) inadequate training, 3) lack of management oversight, and 4) lack of resources. Therefore, in the context of cybersecurity, do you have all of the following: ➤ A procedure or work instruction for cybersecurity ➤ Cybersecurity training for your software development team ➤ Routine monitoring and assessment of cybersecurity ➤ Internal and external resources to manage cybersecurity WI-007 510(k) Software Documentation & Cybersecurity Work Instruction ➤ https://medicaldeviceacademy.com/cybe... AAMI TIR57:2016 ➤ https://webstore.ansi.org/standards/a... ISO/IEC 27001:2017 ➤ https://www.evs.ee/en/evs-en-iso-iec-... ISO/IEC 27002:2016 ➤ https://www.evs.ee/en/evs-en-iso-iec-... ISO 27799:2016 ➤ https://www.evs.ee/en/evs-en-iso-2779... 2014 FDA Guidance ➤ https://www.fda.gov/files/Content-of-... 2016 Postmarket Management of Cybersecurity FDA guidance ➤ https://www.fda.gov/regulatory-inform... Timestamps 0:00 Intro to cybersecurity risk management 3:49 Procedure or work instruction 7:15 Training 8:36 Monitoring and assessment 11:00 Internal resources, suppliers & independence 17:42 Next week we talk about De Novo Strategy

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