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.

 

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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Production & Quality System Software

This course is designed to understand what is and what is not production and quality system software that is required to be validated by FDA and ISO 13485 and will show the methods and tools used to validate Process and Quality System using a software lifecycle process. 

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Medical Device Software Validation 

Registrants should expect complete coverage of Medical Device Software Requirements as they align with  FDA QS Regulation & Guidance,​ as well as ANSI/AAMI/IEC/ISO Standards​.  They will become familiar with industry Best Practices and learn how industry leaders address Medical Device Software Development and Validation​.  Through hands-on exercises and peer discussion, attendees will build a solid understanding for developing and applying Software Validation requirements.

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