Tech For MedTech: Automated Compliance w. Michael Edenzon

One medical device company cut their software recall response time from 180 days to under 30 by automating compliance evidence collection.

In regulated industries like MedTech, shipping software takes weeks not because the code isn't ready, but because proving compliance requires manual evidence gathering. Automated governance captures proof continuously as developers work. When it's time to ship, compliance happens automatically or developers get blocked. The result: 85% faster time to market and developers who become collaborators instead of adversaries.

In this episode, Shannon Lantzy talks with Michael Edenzon, CEO of Fianu, about turning cyclical compliance work into continuous automation, why transparency changes developer behavior, and why objective, reproducible evidence should be the new regulatory standard.

Timestamps:

00:00 – Why automated governance is the missing piece in DevOps

04:00 – How Michael went from constitutional law student to software governance innovator

06:00 – What automated governance is (and why it's not just another tool)

09:00 – The screenshot problem: When developers game manual compliance systems

12:00 – Do developers hate automated governance or does it free them?

15:00 – What happens when requirements are incomplete or wrong

18:00 – The flywheel effect: How continuous feedback improves control effectiveness

20:00 – Creating a shared language: Pass, fail, in progress, or not found

24:00 – Case study: How a CGM company cut recall response from 180 to 30 days

30:00 – Why you should never automate to a higher standard than you're currently at

33:00 – Simulating the impact of policy changes before enforcing them

37:00 – The power of annotations: Accepting risk while maintaining auditability

40:00 – Why transparency turns developers into your best collaborators

42:00 – Who should (and shouldn't) adopt automated governance

48:00 – What Michael would change about FDA regulation if he could wave a wand

52:00 – Tracking software from Jira story to production runtime and back to adverse events

54:00 – What's next for Fianu: Statistics, reporting, and compliance incentive structures

Follow Shannon and Michael:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy/

Website: https://www.shannonlantzy.com/

Connect with Michael: 

LinkedIn: https://www.linkedin.com/in/michaeledenzon/

Website: https://www.fianu.io/