Mar

2003

FDA Food Safety Presentation- Part 11 Redirection

At a Food Safety Conference FDA’s CDRH Software Compliance and Part 11 Representative (John Murray) gave a new presentation on FDA’s changes in its approach to Part 11. The presentation is an improvement to a presentation Mr. Murray gave at the March 2003 AAMI standards conference. The slides from this presentation are at the link provided.

Mr. Murray verbally expressed that this is a significant shift and he believes FDA is committed to resolving the problems and burden of prior Part 11 interpretations.

A Part 11 Redirection Q&A presentation by Alan Kusinitz of SoftwareCPR and an implementation presentation by Carl Wyra presented and a presentation by Mr. Murray at the March 2003 AAMI Standards Conference are also available in the library portion of www.softwarecpr.com. Just search for “redirection”.

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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

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.

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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

FDA Food Safety Presentation- Part 11 Redirection

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