The San Diego-based company said it completed its Stage 1 ISO 13485:2016 audit, conducted by BSI, its Notified Body and Registrar. This audit evaluated its quality management system for compliance and alignment with EU MDR requirements. It confirmed robust, well-documented quality management, the company said, with no major nonconformities identified.
Modular Medical said this marks the next step toward bringing its next-generation Pivot device to the market. It can now advance to a Stage 2 audit in early 2026, marking the final step before achieving the required ISO 13485 certification. In parallel, it plans to begin preparations for its CE technical documentation review under EU MDR. It expects this to commence later in 2026.
Each certification marks a step for Modular Medical toward its planned commercial launch for Pivot in Europe. Pivot remains investigational around the world.
“This milestone reflects the dedication of our team and our commitment to bringing innovative, patient-friendly, insulin delivery solutions to market in Europe and beyond,” stated Jeb Besser, CEO of Modular Medical.
Modular Medical’s current pump, the MODD1, won FDA clearance nearly a year ago. It has microfluidics technology that allows for the low-cost pumping of insulin.
The company announced earlier this year that it began converting its manufacturing line to prepare for production of Pivot, its next-generation insulin patch pump technology.
Pivot aims to simplify diabetes care, the company says. Modular Medical designed its new pump for “almost-pumpers,” targeting adults with a user-friendly, affordable design.
