Software and Cybersecurity
If you oversee compliance activities related to software validation, regulatory affairs, or quality assurance, then this training is for you.
For virtual training courses, please allow one week for US addresses and two weeks for international addresses for shipping of training materials and devices. If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course. If you have any questions, please email education@aami.org.
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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Risk-Based Computer Software Assurance Approach for PPQS (July 2023)
July 11 to 13, 2023Register
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Production and Quality System Software (Aug 2023)
August 16 to 17, 2023Register
Medical Device Software Validation
Learn how to develop and validate medical device software in an ever-changing landscape of regulations and technology. This class will ground you in all the relevant regulations, standards and guidance and help you understand how risk, cybersecurity, cloud computing and mobile apps impact the medical device software space. .
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Medical Device Software Validation (Nov23)
November 7 to 9, 2023Register