Software as a Medical Device (SaMD) Validation Training
This Training outlines the regulatory requirements, general principles, software lifecycle and development activities, design phases, and deliverables. It outlines software testing for verification and validation to ensure patient safety.
What is Validation Training?
The training will show you software validation is a process within the software development life cycle that ensures a software application or system meets its intended requirements and performs as expected in its specific environment. It involves evaluating and verifying that the software functions correctly, adheres to its design specifications, and meets the user’s needs and expectations.
How does medical software validation work?
SaMD validation differs from hardware validation in that the focus for SaMD is software’s functionality, safety, and effectiveness. The testing is also different. Thex testing includes functional testing, usability testing, security testing, and performance testing.
What’s included in the medical device software validation training?
- Rook Template Software Validation Powerpoint
- Rook Template Software Validation Training Quiz
- Rook Template Software Validation Training Quiz Key
Rook Template Software Validation Powerpoint
The training specifically goes over the fda requirements, defines software requirement specifications, activities in the software lifecycle activities, and the requirements for the stages of software development.
Rook Template Software Validation Training Quiz
The software validation quiz ensures that you know validation and the contents of the software lifecycle.
RookQS can help with SaMD validation & training
Rook can walk you through the powerpoint material and walk you through your graded quiz. We can also support in answering specific questions related to a particular device. We can assist in answering questions about documentation and getting your QMS started for your SaMD.