November 16, 2015
A new International Medical Device Regulators Forum (IMDRF) document was finalized.  It is Software as a Medical Device (SaMD): Application of Quality Management System.  The objective of the document is to provide guidance on the application of existing standardized and generally accepted QMS practices to SaMD. View the document at this link:  imdrf-tech-151002-samd-qms
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Company: Hamilton.Medical Date of Enforcement Report 8/26/2015 Class l: PRODUCT The G5 ventilator provides breathing support for adult, children, infant and newborn patients. The device is intended for use in hospital and other health care facilities. It may be used for transport within a hospital or health care facility. REASON The ventilator may stop working,...
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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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