Nocat Archives

FDA User Fee Reauthorization Bill Omits Medical Device Security

October 10, 2022Allison PateNocat

(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

Jul

Recall- Risk of Software Error Leading to Medication Error

July 22, 2022Allison PateNocat

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...

Jul

July 2021 SoftwareCPR Newsletter

July 30, 2021Jordan PateNocat

Jun

June 2021 SoftwareCPR Newsletter

June 20, 2021Jordan PateNocat

Jan

SoftwareCPR January 2021 Newsletter

January 27, 2021Amy SellersNocat

Nov

SoftwareCPR November 2020 Newsletter

November 4, 2020Amy SellersNocat

Oct

Recall – Radiology software defect may result in missing images

October 14, 2020Jordan PateNocat

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...

Feb

Reclassification of Medical Image Analyzers

February 27, 2020Brian PateNocat

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...

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

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