BOZEMAN, Mont — Golden Helix, Inc. announced that it has received the certification for ISO 13485:2016 from TÜV SÜD.
ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, development, production, and servicing of medical devices. It is specifically tailored to the medical device industry and is recognized globally as a benchmark for ensuring the quality and safety of medical devices.
“We are very pleased to receive ISO 13485:2016 certification. It’s a testament to our efforts of continuous quality improvements, including our software development processes, customer success and support processes, and all other operational processes within our company,” says Dr. Andreas Scherer, President and CEO of Golden Helix. “ISO 13485:2016 is designed to objectively document that we are holding ourselves to the highest quality standards as we are providing innovative solutions to hospitals, testing labs, and research institutions globally.”
In order to be certified, an organization has to maintain a quality management system, demonstrate sufficient risk management, and show consistent tracking of customer satisfaction and safety in the market as well as demonstrate continued improvement efforts on the product and system level.
About Golden Helix
Golden Helix has been delivering industry-leading bioinformatics solutions for over a quarter century with thousands of users worldwide. Golden Helix enables hospitals, testing labs, research institutions, and country-wide genome initiatives to conduct a wide spectrum of clinical tests and facilitate genomic research. With its solutions, Golden Helix users can harness the full potential of genomics to identify the cause of disease, gain diagnostic insights, and improve the safety and efficacy of treatments, helping to realize the promise of personalized medicine.