We are proud to announce that our Quality Management System has achieved ISO 13485:2016 certification!
ISO 13485 is an internationally recognized standard that sets out the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Our certificate has been awarded for the design and development of reagents and consumables for use with in vitro diagnostic assays for molecular testing.
“We are thrilled to have achieved ISO 13485 certification,” said Barnaby Balmforth, PhD, Biofidelity Co-founder and CEO. “This certification is a testament to our team’s continued hard work and our commitment to providing the highest quality products to our customers.”
“Customers can be confident that our reagents and consumables are designed and developed in an environment of quality and improvement,” said Simon Knight, Biofidelity Director of Quality. “Receiving ISO 13485 certification is a tremendous stamp of approval for our Quality Management System, and provides a great platform to move us forward as the scope of certification expands over time.”
View the certificate here.
About Biofidelity
Biofidelity is a rapidly growing commercial-stage genomic technology company dedicated to bringing the benefits of precision medicine to patients around the world.
Aspyre®, the first application of our novel molecular biology technology platform, makes genomic analysis simpler, faster, and more efficient. With the ability to harness existing instrumentation commonplace in laboratories worldwide, Aspyre provides straightforward, cost-effective access to the vital information needed for accurate targeting and monitoring of cancer treatment.
Founded in 2019, Biofidelity is comprised of scientists, engineers, physicians and commercial experts dedicated to making genomics globally accessible. For more information, please visit biofidelity.com and connect with us on LinkedIn and Twitter.
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