Company: Sunquest Information systems, aka Misys Healthcare
Date of Enforcement Report: 5/1/02
Class: II
PRODUCT
Misys Laboratory Microbiology Module, Recall # Z-0916-2.
REASON
Software does not allow comments to be shown in some reports.
CODE
Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Sunquest Information systems, aka Misys Healthcare, Tucson, AZ.
Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
735.
DISTRIBUTION
Nationwide and Internationally.
IEC 62304 and other emerging standards for Medical Device and HealthIT Software
Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.
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Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!
3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.
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Next public offerings:
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This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.
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Next public offering: TBD
