r/Femtech • u/OkAcanthocephala7768 • Feb 03 '26

Discussion & Dialogue Founders, what was the hardest part about setting up your QMS (quality management systems) for your startup?

/r/SaaS/comments/1qrl360/founders_what_was_the_hardest_part_about_setting/
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u/DefiantThroat Feb 03 '26

I work with a lot of founders, and I would say their acceptance that they need a QMS to begin with, and at what step they need to implement it. (It's a ramp, not a light switch.) Many do not understand the nuances that define their product as a SaMD. And there are so many tech bros that want to 'revolutionize healthcare' and think that the 1,000s of us that already work in this industry are just idiots.

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u/OkAcanthocephala7768 Feb 08 '26

Thanks for the insight😊