Dec

1997

Sor-Van Radiation Ltd.

b. Changes made to the software program for the _____ have not been formally reviewed and approved by designated representatives of the firm…..Your response is not adequate because it does not include documentation showing formal review and approval of the software program changes.

a. A user manual (or SOP) is not available for the _____ computer software that controls the _____ system.

b. There are no written, reviewed and approved, specifications for the software program for the _____ system.

The response is not adequate because no documentation was provided showing approved specifications for the software program for the _____ system.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Being Agile & Yet Compliant (Public)

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

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

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

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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

Sor-Van Radiation Ltd.

Amy Sellers

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