Molecular Designs, a developer and manufacturer of molecular multiplex pathogen assays, announced the successful completion of a recent ISO 13485:2016 inspection and certification of its Quality Management System.
ISO certification demonstrates the company’s commitment to design, develop, produce, and deliver PCR-based assays that meet strict quality standards, according to Molecular Designs.
ISO 13485:2016 is an internationally recognized quality standard, published to support medical device manufacturers, by defining requirements for a quality system that supports the delivery of medical devices that consistently meet customer requirements and that are safe for their intended use.
“We are proud to be recognized for our commitment to quality at Molecular Designs through our recent ISO 13485:2016 certification,” says Ted Kramm, CEO of Molecular Designs. “Our priority is to supply high-quality, cost-effective, and easy to use multiplex assays to laboratories and developers of assays. Our continued goal is to bring to market many assays currently in development that will serve to advance molecular diagnostics.”
Molecular Designs was founded by physicians looking to simplify delivery of and increase accessibility to cost-effective, streamlined, easy to use molecular technologies to laboratories, according to the company. It offers numerous multiplex PCR-based panels produced under ISO 13485:2016 quality standards for research use only.
