TIR45 | An AGILE Approach to Software Regulatory Requirements

BeanStock Ventures brought together a panel of medical device software experts to bridge the gaps between modern software development and regulatory requirements.

AGILE development can maintain its adaptive nature while still being complaint by following guidance provided by TIR45, a recognized consensus standard by the FDA, among other best practices. This panel de-mystifies the beliefs that Agile development lacks the proper controls for producing safe and effective software and that the regulation is burdensome. The panelists share experiences, ideas and tools used to be compliant and still be adaptive and effective.

Learn more about our partnership with BeanStock Ventures