NEW YORK (GenomeWeb) – Kapa Biosystems today announced that it has received ISO 13485:2003 certification for the design, development, and manufacturing of molecular diagnostic kits and reagents for in vitro diagnostic applications.
To achieve the certification, Kapa expanded its quality management system, streamlined processes, implemented a validation program, and introduced additional risk-management steps, the firm said in a statement.
Luan Webber, Kapa Quality Assurance Manager, said that achieving ISO certification was a "critical step" for the Wilmington, Massachusetts-based firm. The firm can now begin producing reagents for use beyond the research market.
The certificate was granted by Lloyd's Register Quality Assurance.
Kapa supplies reagents to optimize enzymes in next-generation sequencing and PCR research applications. In August, Roche announced an agreement to acquire the firm for an undisclosed amount.