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April 7, 2021
(April 6, 2021)— Ginny Kwan Gattinger has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR®) as a Partner. Ginny is a regulatory affairs professional specializing in software-based products with over 10 years of experience in the regulated industry including medical devices, pharmaceuticals and biotechnology. Ginny has developed regulatory strategies for a variety of SiMD/SaMD and...
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Company: Biocare Medical, LLC Date of Enforcement Report: 4/7/2021 Class II PRODUCT BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: ” Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 Recall Number: Z-1333-2021 REASON Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction...
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Company: Philips North America, LLC Date of Enforcement Report: 4/7/2021 Class II PRODUCT Philips SureSigns VM4, VM6 and VM8 – Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi”gns VM8 (863066, 863068,...
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Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/october-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

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Partners located in the US (CA, FL, MA, MN, TX) and Canada.