Ncardia announces ISO certification of its manufacturing site

09 January, 2018

Date: December 18, 2017

Ncardia is proud to announce the achievement of ISO 9001:2015 certification confirming its commitment to excellence and customer satisfaction.

Ncardia, a global leader developing stem cell models and solutions for cardiovascular and neuro drug discovery is proud to announce ISO 9001:2015 certification of its manufacturing site from the International Organization for Standardization (ISO), effective as of 15. Dec. This certification is an important step in further ensuring that Ncardia customers continue to receive the very best in quality products and services from Ncardia.

International Organization for Standardization (ISO) 9001:2015 is the latest version of the well-recognized international standard that specifies requirements for the company-wide Quality Management System (QMS). It establishes an effective quality management program for manufacturing companies and helps organizations consistently meet the needs of customers and other key stakeholders in both the delivery and continuous improvement of products and services.

“Certification of our Manufacturing and QC processes is an important step for Ncardia since hIPSC cell products are increasingly considered for regulatory safety testing of novel drug candidates” said Stefan Braam, Ncardia CEO. “Our strict quality management system confirms to our customers our desire to always perform at the highest levels of quality and efficiency and our focus on continuous improvement and customer satisfaction. This ISO certification is essential to further delivering innovative, high quality and customer-focused hiPSC-derived cells based solutions.”

“We are extremely proud of our team and their efforts in attaining the ISO 9001:2015 certification” says Eva D’Amico, Manufacturing Manager. “We always consider quality and customer satisfaction as our priorities. ISO 9001:2015 certification reflects our commitment to quality and our commitment to our customers.”

About Ncardia

Ncardia develops, produces and commercializes highly predictive human cellular assay systems for safety and efficacy testing. The product portfolio encompasses a broad panel of hiPSC derived cryopreserved cardiomyocytes and neurons. In addition, the company delivers the CardioPlateTM product line of quality controlled ready-to-use assay plates. Using its cell products, Ncardia develops and provides its customers with a broad portfolio of cardiovascular services from safety pharmacology and disease modeling to cardiovascular drug efficacy screening. Ncardia is based in Belgium, The Netherlands, Germany, and the USA. The company is privately held and was established in September 2017 following the merger of Pluriomics and Axiogenesis, two well-known pioneers in the field of stem cell-derived cells for safety and toxicology assessment.

For more information please visit www.ncardia.com

For more information please contact:


Celine Hechard

+31 (0) 713322230