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November 15, 2022
15
Nov

Dr Peter Rech Reappointed Convener for Infusion Pumps

November 15, 2022
Crisis Prevention and Recovery, LLC / SoftwareCPR, Tampa, FL USA – (November 15, 2022) “We are pleased to announce that our partner, Dr Peter Rech, has been reappointed to serve the next 3 years as convener for IEC technical committee 62/SC 62D/MT23 Infusion Pumps.  In this role, Dr Rech will be responsible for organizing and administering...
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15
Nov

FDA Updates Cybersecurity Playbook

November 15, 2022
FDA Updates Cybersecurity Playbook for Health Care Organizations The healthcare sector knows how to prepare for and respond to natural disasters. It is less prepared, however, to handle cybersecurity incidents, particularly those involving medical devices.  With healthcare-related cyber incidents growing in size and scope, preparedness before a cyber event takes place with a strong, well-exercised,...
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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