21
Jan
1998

Mennen Medical Ltd. Paient Monitors

0

Mennen Medical Ltd. 1/21/98 Patient Monitors

c. The approval page for the Horizon 9000WS Cathlab’s software located in the document control department contained the signature of the originator of the document, but it lacked an approval signature. This approval page was different from the approval page for the same software located in the production department. The approval page located in the production department contained an approval signature, but it lacked the identity of the person responsible for initiating revision E through H.

About the author

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.

Instructor: Brian Pate

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Private, in-house courses can be scheduled. Contact us.

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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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