BOZEMAN,
Mont, Feb. 1, 2024 /PRNewswire/ -- 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.
Casey Fullem
Director of Marketing
Golden Helix, Inc
(406) 551-4901
fullem@goldenhelix.com
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SOURCE Golden Helix Inc