Enzyme was developed by software engineers to support complex medical technology that increasingly relies on embedded, web and mobile software to serve patients and clinicians. We also know the FDA, ISO13485 very well and have some suggested ways on how to mesh the traditional waterfall style design process with the needs of fast moving, agile software teams.

The requirements of FDA 21 CFR 820.30:1997 often appear to require a rigid waterfall style development which most modern software teams would struggle to comply with. 

Enzyme makes compliance drastically easier by tracing design control element to the existing artifacts generated by the software tools engineers already know and love (we have 10+ integrations). 

  • Epics can be imported from a task management tool like Jira or Pivotal.
  • Stories are similar, with the exception that they will be stories or issues, rather than epics. 
  • Design Outputs will be code that is merged into your production release Master branch and can be imported from GitHub, GitLab, Bitbucket and Jira. 
  • Verifications will be test artifacts from your a continuous integration service (CircleCI, TravisCI, Jenkins, and Jira) running builds of unit and blackbox tests that ensure requirements were met.
  • Validations & validation testing can be important from a task management tool like Jira and Zephyr.

Note: Whomever sets up the integrations will need to be a Quality Owner in Enzyme and typically had Admin level permissions in the target service.

Enzyme also supports creating tracings from within these tools. As well, for some integrations, we will write data back to the integration in order to keep context current in both systems. 

This workflow is harmonized with the software development procedures we provide.

Getting everything setup and your team acclimated can take some adjustment. Please contact us so we can recommend a tailored solution for you team.

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