International standard registration will facilitate access to new markets
Celsee Diagnostics, an innovator of cutting-edge rare cell isolation and characterization products for both clinical and research applications announced today its successful ISO13485:2003 registration
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
“The ISO 13485:2003 certification will facilitate Celsee Diagnostics’ access to new markets while conforming to regulatory requirements,” stated Zach Bazzi, Director of Quality Systems and Compliance, Celsee Diagnostics. “In addition, the certification establishes Celsee Diagnostics’ credibility and commitment to quality and patient safety.”
Global national regulatory authorities either require, or strongly prefer, that manufacturers marketing medical products in their countries have a third-party audited and certified quality management system in place.
“Investing in a quality system speeds up Celsee Diagnostics’ access into countries that require the ISO13485:2003 certification, and expedites market entry into other countries,” stated Kalyan Handique, Ph.D., CEO & President, Celsee Diagnostics.
“Based on a uniform and widely-accepted system of process control, the certified quality management system will help us improve products and processes. This in turn will foster improved relationships with our suppliers, business partners, and customers, and provide us an advantage in the marketplace.”
The ISO certification was issued by the BSI Group.
About Celsee Diagnostics
Celsee Diagnostics, a privately-held Michigan-based company, develops automated systems for rare cell enrichment and single-cell analysis. The label-free Celsee PREP platforms perform all the required processing steps to isolate and execute downstream single-cell analysis including immunochemistry, DNA FISH and mRNA FISH, while the Celsee ANALYZER scans and analyzes the prepared slide automatically. Alternatively, isolated cells can be retrieved for off-chip analysis, such as NGS, PCR or culture.