All Medicinal Genomics products are manufactured in ISO-certified facilities. While MGC develops and tests all reagents in-house, the commercial-scale production is carried out by trusted ISO-certified manufacturing partners.
Commitment to Quality
At Medicinal Genomics, we maintain a robust internal quality system designed to meet the standards of ISO 9001, ISO 13485, and CLIA. Many members of the MGC team bring experience from Courtagen Life Sciences, a clinical sequencing diagnostics company, making quality practices a fundamental part of our culture. We conduct all aspects of our business in alignment with these rigorous standards.
ISO 17025 Audits
ISO/IEC 17025 accreditation, granted by a recognized third-party body, demonstrates a laboratory’s technical competence to perform specific tests and calibrations. Accreditation involves a rigorous assessment against the ISO/IEC 17025 standard, which defines the general requirements for the competence of testing and calibration laboratories. While this process is voluntary, it is often required by regulatory agencies and expected by customers as a mark of quality and reliability.
Medicinal Genomics reagents and methods are fully compatible with ISO 17025-accredited operations. Laboratories undergoing accreditation or audits by third-party bodies such as Perry Johnson or A2LA can confidently use our products. We currently partner with over 100 ISO 17025-accredited laboratories across the United States.
Applicability of ISO 17034
ISO 17034 outlines the general requirements for the competence and consistent operation of reference material producers (RMPs), including those that manufacture certified reference materials (CRMs) such as NSI Lab Solutions. It provides a framework for demonstrating the ability to produce high-quality, consistent reference materials.
ISO 17034 does not apply to Medicinal Genomics, as we do not manufacture or sell certified reference materials or proficiency tests. While we do offer synthetic DNA controls used as positive controls in our assays, these are sometimes mistakenly identified by auditors as reference materials. However, they are not produced or marketed as certified reference materials under the scope of ISO 17034.
Our Trusted Manufacturing Partners
Medicinal Genomics collaborates with leading reagent manufacturers to produce and package our custom master mixes, oligonucleotides, and DNA extraction kits that form the core of our product lines.
All MGC reagents are manufactured in ISO-certified facilities. Certification documents are available for download below.
Meet our Partners:
- New England Biolabs in Ipswich, Massachusetts: https://www.neb.com/about-neb/certifications
- Integrated DNA Technologies in Coralville, Iowa: https://sfvideo.blob.core.windows.net/sitefinity/docs/default-source/miscellaneous/certificate-iso-9001-2008eb2f621532796e2eaa53ff00001c1b3c.pdf?sfvrsn=d0183407_66
- AmericanBIO, Inc in Canton, MA: American BIO Inc, ISO 13485 Certificate
- Agilent Technologies in Santa Clara, CA: Agilent ISO 13485 Certificate Agilent MDSAP Certificate