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by ware_am_i 2174 days ago
Completely agree, and feeling most of these pain points in the medical device / diagnostics industry as well. There are so many black boxes and unknown-unknowns in this space, especially when it comes to developing indications and navigating regulatory interactions. That's a main driver of why we built Essenvia (https://www.essenvia.com/#/), which automates the creation and submission of all regulatory docs required for medical device approval. We're expanding next into other aspects of the industry (complaint handling, compliance testing) as well as adjacent industries (environmental, pharma, etc.).