Software & Cybersecurity

AAMI’s Software/Cybersecurity suite of courses are intended for those who oversee compliance activities related to software, validation regulatory affairs/quality assurance specialist professionals, those who require technical training on development and validation activities, and those seeking to understand agile principles and practices.

Developing and Validating Software for the Medical Device Industry

Learn how to design software validation plans that build confidence in the software and comply with regulatory requirements for device, commercial off-the-shelf, and quality system software; use risk management to focus validation activities to minimize risk; streamline elements of the quality system for cost-efficient validation; select appropriate life-cycle models; synchronize validation activities for all types of software; and integrate best development engineering practices to support validation efforts.

12th of October 2020, Dublin, Ireland

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Effective Application of Agile Practices in the Development of Medical Device Software

Learn how to evaluate the challenges with the use of Agile practices and adapt these practices to ensure the development of compliant, safe, and effective products. This course builds on the concepts in AAMI TIR45: Guidance on the use of AGILE practices in the development of medical device software.

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Application of Agile to the Development of Medical Device Systems

For many years, software development teams have been using Agile software development methods, but Agile is not just for software. Agile’s lean product development principles also apply to the development of hardware-based products and systems. Go beyond small-team and softwareonly applications and discover how Agile practices can be used in the development of medical device systems

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