Company: Misys Healthcare Systems
Date of Enforcement Report: 8/10/05
Class: II
PRODUCT
Misys Laboratory, Version 6.1, Recall # B-1566-5
REASON
Defects in the design of software could result in loss of patient information.
CODE
Version 6.1
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by facsimile and e-mail dated May 20, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide, UK and Denmark
Being Agile & Yet Compliant (Public)
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:
IEC 62304 and other emerging standards for Medical Device and HealthIT Software
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Registration Link:
TBD
Medical Device Cybersecurity (Public or Private)
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2-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Dr Peter Rech, 2nd instructor (optional)
Next public offering: TBD
