WILMINGTON, Mass.--(BUSINESS WIRE)--Kapa Biosystems today announced that it has earned ISO 13485:2003 certification for the design, development, and manufacturing of molecular biology kits and reagents for in vitro diagnostic applications. This certification is recognized as the international quality standard for medical devices.
The achievement affirms that Kapa’s manufacturing process is qualified to produce safe and effective medical devices, or components of them, and enables the company to begin producing reagents for use beyond the research market. To prepare for certification, Kapa expanded its quality management system by streamlining certain processes, implementing a validation program, and introducing additional risk-management steps.
“Kapa has always been dedicated to designing and building products with stringent quality control, and this certification recognizes our commitment to ensuring the highest standards as we evolve to provide solutions for the clinical market,” said Luan Webber, Quality Assurance Manager at Kapa Biosystems. “This milestone is a critical step in our efforts to deliver industry-leading reagents to any lab using genomic tools.”
The International Organization for Standardization, or ISO, is the world’s largest developer of international standards. Kapa’s ISO 13485:2003 certificate was granted by Lloyd’s Register Quality Assurance (LRQA).
For more information, please visit www.kapabiosystems.com.
About Kapa Biosystems
Kapa Biosystems is a life science reagents supplier that employs proprietary, directed-evolution technologies to optimize enzymes for next-generation sequencing (NGS), PCR and real-time PCR applications. Kapa Biosystems offers a portfolio of best-in-class products containing novel enzymes that confer significant performance advantages when compared to traditional wild-type enzymes. The company is based in Wilmington, Massachusetts, with a research, development, and manufacturing facility in Cape Town, South Africa. For more information, please visit www.kapabiosystems.com.
Kapa Biosystems’ products are for Research Use Only; not for use in diagnostic procedures.
