Regulating Software Used by Life Science Manufacturers - Webinar Recording/Transcript
Regulating Software Used by Life Science Manufacturers: Is it a Medical Device or Not?
Life science companies using software in clinical trials, software developers, and producer of artificial intelligence products need to know what software is a medical device and what’s not.
Life science companies utilizing AI or buying off-the-shelf software products often don’t realize that they’re using those products as medical devices and that significant fact impacts the ability to get their device approved and the validity of the data they’ve collected and compiled.
Many life sciences manufacturers simply don’t realize their product will be considered a medical device and don’t know what regulations apply. James Rogers, founder and head of Compass Life Science Solutions, has more than 20 years experience dealing with compliance requirements. Over the course of 90-minutes he’ll help you understand:
- The process by which to classify an SaMD based on U.S. and international guidance
- How a company’s use of a software product impacts the classification of SaMD
- When a purchased software product becomes an SaMD
- Remediation approaches to resolve SaMD compliance issues
- Best practices on development and validation strategies for SaMD
This presentation will help you assess your software products and implement software development and validation best practices.