PrimeraDx, a developer of molecular diagnostics assays, has obtained ISO 13485:2003 certification.
The review was performed by BSI Group America according to ISO 13485:2003 requirements and focused on PrimeraDx’s design, manufacturing and distribution of multiplex instrumentation and assays for molecular diagnostics.
PrimeraDx CEO and president Matt McManus said the certification demonstrates to their customers, collaborators and companion diagnostic partners, that they are dedicated to quality at every level of the organization.