Mon, 01/12/2026 - 12:03
Early-stage medtech companies are under tremendous pressure to develop quickly, prove value, and obtain regulatory approval or clearance as fast as possible. The pace of innovation in the industry has increased tremendously, thanks to more options…
Mon, 12/01/2025 - 12:03
The quality systems most medtech teams are stuck with aren’t built for how they work today. 21 CFR Part 820 was authorized by the Federal Food, Drug, and Cosmetic Act of 1978, long before the software industry even existed. And while the regulations…