Watchmaker Genomics is proud to announce that its 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 for the medical device industry. Our certificate has been awarded for the design, development, manufacture, contract manufacture, distribution, and support of high-performing reagents for genomic applications in medical research.
“We are thrilled to have achieved ISO 13485 certification,” states Trey Foskett, Co-Founder, and CEO at Watchmaker Genomics. “This certification is a testament to our team’s hard work and dedication to providing our customers with the highest quality products and services. We are committed to maintaining this standard and providing our customers with the best experience possible.”
“Our customers can be confident that our products are designed, developed, and manufactured in an environment of quality and improvement,” states Peter Bruesehoff, Director of Quality Assurance at Watchmaker Genomics. “Receiving ISO 13485 certification enables us to meet and hopefully exceed our customers’ expectations, particularly in the field of molecular diagnostics, which may be regulated as medical devices.”
About Watchmaker Genomics
Watchmaker Genomics applies advanced enzymology to enable breakthrough applications for the reading, writing, and editing of DNA and RNA. The company combines deep domain expertise in protein engineering with large-scale enzyme manufacturing to address the demanding quality, performance, and scale requirements of high-growth genomics applications.
Watchmaker’s product portfolio includes enzymes and kits for next-generation sequencing library preparation, synthetic biology, and molecular diagnostics. Based in Boulder, Colorado, Watchmaker Genomics is co-founded by Trey Foskett, Brian Kudlow, and Stephen Picone. The team brings decades of collective experience building successful life science companies, commercializing novel technologies, and advancing clinical genomics applications. Watchmaker partners directly with innovative life science companies, commercial sequencing providers, and pioneering research labs.
Contacts
If you have any questions or want a copy of our registration certificate, please do not hesitate to contact us at quality@watchmakergenomics.com.