Oct

2013

First AAMI Agile Software Compliance Course

Last week was the first offering of AAMI’s course on Agile Software Methods Compliance. Approximately 30 students attended from a wide range of medical device manufacturers including software engineers, quality, compliance, and regulatory managers. As a first offering this level of enrollment shows the high interest in more efficient and effective approaches to medical device software.
Brian Pate and Alan Kusinitz of SoftwareCPR as well as Kelly Weyrauch of Medtronic served as instructors. AAMI is currently scheduling the second offering in the first half of 2014. For more information leave a message on our site or email training@softwarecpr.com. SoftwareCPR can also provide on-site consulting and training to assist you in efficient and compliant Agile implementations tailored to your quality system, culture, device type, and preferences.

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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.

Instructor: Brian Pate

Next public offering: June 24-26, 2025 (Boston, MA)

Multiple participants from the same company: If you register 5 or more from the same company before March 15, 2025, receive a special discounted registration of $1999 per person. These registrations may be transferred to another person at any time. Email training@softwarecpr.com to register and secure the TEAM discount.

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

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
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

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

Lead Instructor: Mike Russell

Next public offerings:

Americas: 11-13 February 2025
EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
Southern Central Northeastern Pacific: 24-26 February 2025

See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

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

First AAMI Agile Software Compliance Course

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