Category

Nocat
Company: Getinge Usa Sales Inc Date of Enforcement Report: 1/26/2023 Class I PRODUCT Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400 Programmable Diagnostic Computer Recall Number: Z-0959-2023 REASON Due to a software bug, under certain conditions, pressure cannot be built up resulting in no...
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Company: Align Technology Inc. Date of Enforcement Report: 1/26/2023 Class II PRODUCT Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 Recall Number: Z-1017-2023 REASON 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than...
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Company: Agfa Healthcare NV Date of Enforcement Report: 1/20/2023 Class II PRODUCT Agfa HealthCare Enterprise Imaging XERO Viewer Recall Number: Z-0775-2023 REASON There is a software defect that can cause issues with images. RECALLING FIRM/MANUFACTURER Agfa Healthcare NV VOLUME OF PRODUCT IN COMMERCE 110 units DISTRIBUTION Distribution throughout US OUS distribution to Australia, Belgium, Brazil,...
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(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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MicroVention located in Costa Rica was issued a warning letter from the FDA for reason “that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of...
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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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SoftwareCPR Training Courses:

Risk Management (Public or Private)

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

  • 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

Next public offering:  TBD

 

Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

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

Instructors: Mike Russell, Ron Baerg

Next public offering:  TBD

 

Medical Device Cybersecurity (Public or Private)

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.

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

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

 

IEC 62304 and other emerging standards for Medical Device and HealthIT Software (Public or Private)

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.

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

Instructor: Brian Pate, 2nd instructor (optional)

Next public offering:  TBD

 

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