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Nocat
(October 6, 2022. Health IT Security) The FDA has issued a user fee re-authorization bill but due to fast approaching deadlines among other constricting legislative factors, the House bill has left out medical device security leaving some experts weary of it’s consequences. https://healthitsecurity.com/features/experts-weigh-in-on-medical-device-security-exit-from-fda-user-fee-bill
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Company: Baxter Healthcare Company Date of Enforcement Report: 7/22/2022 Class I PRODUCT ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393...
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Company: CHANGE HEALTHCARE CANADA COMPANY Date of Enforcement Report: 10/14/2020 Class II PRODUCT Change Healthcare Radiology Solutions 14.0 Recall Number: Z-0072-2021 REASON Software defect which may potentially result in one or more images missing in a study. RECALLING FIRM/MANUFACTURER CHANGE HEALTHCARE CANADA COMPANY on 8/25/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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FDA has issued a final order to reclassify: medical image analyzers applied to mammography breast cancer ultrasound breast lesions radiograph lung nodules radiograph dental caries detection all which are post-amendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician’s...
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Upcoming SoftwareCPR Training Courses:

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.

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 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

 

Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:

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

 

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