Mar

1997

Irwin Memorial Blood Centers Blood Center

Irwin Memorial Blood Centers 3/20/97 Blood Center

Please be advised that the agency’s memorandum dated April 6, 1988, entitled “Recommendations for Implementation of Computerization in Blood Establishments” indicates as a data security issue that “if key elements of the database are changed, these changes should be traceable as to the time and person making the changes so that integrity and reproducibility of data are assured.” In addition, the agency’s memorandum dated September 8, 1989, “Requirements for Computerization of Blood Establishments” states that among other requirements, “Security procedures to prevent unauthorized entry and physical access to the computer system” and “Procedure for control of changes in hardware/software” must be incorporated into SOPs. Copies of both these memoranda were provided to your firm with the Warning Letter dated January 13, 1993 and are enclosed with this letter.

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!

Agile principles that align well with medical
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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.

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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)

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Irwin Memorial Blood Centers Blood Center

Amy Sellers

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