Regulating Software Used by Life Science Manufacturers - Webinar Recording/Transcript

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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.

  • Owners of SaMD companies
  • Quality individuals responsible to the use of software in clinical trials
  • Quality individuals responsible for the validation of device software.

James Rogers, founder and head of Compass Life Science Solutions, has more than 20 years experience dealing with the compliance requirements of various standards and regulations. He has helped companies achieve compliance with GAMP, 21 CFR Parts 11, 58, 210, 211, and 820, ISO 9000, 13485 and 14971, IEC 62304, the European MDD and MDR directives, and Annex 11. His industry experience includes the manufacturing of medical devices, and implementing regulatory compliant software and datacenter services. Most recently, Rogers has been working with companies to develop compliance strategies and methodologies to support the utilization of cloud based solutions as medical devices.