Pluri, a biotechnology company headquartered in Haifa, Israel, said it has obtained ISO 9001:2015 and ISO 13485:2016 certifications for its PluriCDMO contract development and manufacturing organization (CDMO) business.

The ISO 9001 certification covers the quality management system supporting research and development of cell-based products and their derivatives. The ISO 13485 certification, obtained in August 2026, covers contract manufacturing services for medical device companies.

The certifications provide independently assessed quality management frameworks for PluriCDMO’s services as it pursues additional customer programs. ISO 9001 applies across industries, while ISO 13485 addresses quality management systems for medical device manufacturing.

PluriCDMO launched in 2024 and provides process development and manufacturing services for cell-based products, supported by the parent company’s cell manufacturing infrastructure and analytical capabilities. The company said it has entered into commercial agreements with multiple customers since launching the business.

In December 2025, Pluri reported expanding a manufacturing agreement with Remedy Cell to support GMP production and process development for a stem cell-derived, cell-free therapeutic candidate. The collaboration included process implementation, engineering runs and clinical-grade batch manufacturing for the candidate’s planned Phase 1b trial.

Pluri said the new certifications complement its existing cGMP-based cell therapy manufacturing capabilities and may help the CDMO qualify for projects with customers whose supplier requirements include ISO 9001 or ISO 13485.