During this 3-day training, 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. It will also challenge you with real-life exercises to give you experience in determining the different classes of software and the activities required for developing and validating that software.
Program Objectives
At the conclusion of this course, you will be able to:
– Explain the Requirements for Developing and Validating Medical Device Software including:
– Laws – 21st Century Cures Act
– Regulations – 21CFR820, EU MDR/IVDR
– Standards – ISO 13485, ANSI/AAMI/IEC 62304:2006/A1:2015, ISO 14971, ANSI/AAMI/IEC80002-1:2009
– Guidance – General principles of software validation, IMDRF SaMD, mobile medical app, cybersecurity premarket, cybersecurity post market, AAMI TIR57 – Medical Device Security, Premarket Submissions from Medical Devices with Software
– Explain the relationship between FDA and MDR Medical Device Classes, Software Safety Classes, and Software Development and Validation Activities.
– Understand the required activities for developing and validating medical device software
– Understand the FDA and EU Regulatory Submission requirements for the various classes of software
For more information: https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y4U00000KEZvn