Day

May 8, 2019
Today FDA issued a final guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.  Guidance for Industry and Food and Drug Administration Staff Document (May 7, 2019).  The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions. In our opinion, early feedback and...
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A 2015 article providing a review of the factors that contribute to a potentially insecure environment, together with the identification of the vulnerabilities, and why these vulnerabilities persist and what the solution space should look like.
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Company: Viewray, Inc. Date of Enforcement Report: 5/8/2019 Class II PRODUCT MRIdian Linac Radiation Therapy System, Model 20000. Recall Number: Z-1251-2019 REASON A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. RECALLING FIRM/MANUFACTURER Viewray, Inc on 3/18/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 5/8/2019 Class II PRODUCT SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. Recall Number: Z-1245-2019 SOMATOM Edge Plus, Model Number 10267000 Recall Number: Z-1246-2019 SOMATOM Definition...
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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

Next public offering:  June 5-7, 2024
Boston, MA

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

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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 (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: February 12-15, 2024

Virtual via Zoom

Registration Link:

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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

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