Felix Schmidt, CEO - Deep Breath Intelligence (DBI)   

“Choosing Effectum Medical’s Legal Manufacturing Services over building an in-house QMS brought several key advantages. First and foremost, the speed to market was significantly accelerated thanks to their QMS, which is fully compliant with EN ISO 13485, MDR/IVDR, and FDA requirements. The onboarding process was highly structured, and their deep regulatory expertise ensured compliance from day one. Additionally, we were able to mitigate the operational and financial burden of building and maintaining a QMS internally, allowing us to remain agile and focused.

Since partnering with Effectum Medical, we have successfully navigated multiple regulatory milestones, including IVDR conformity for software and hardware products. This partnership has enabled us to present a fully compliant QMS to potential investors and strategic partners—an achievement that has materially strengthened our commercial positioning.”