ISO 13485:2003 and QCMD
PathoFinder has a ISO 13485:2003 certified Quality Management System for the production, marketing, sales and distribution of In-Vitro Diagnostics for infectious diseases.
Quality Control for Molecular Diagnostics (QCMD, www.qcmd.org) is an international Extenal Quality Assessment (EQA) provider for molecular diagnosis of infectious agents. QCMD has a extensive EQA portfolio with a wide range of clinical relevant infectious diseases and includes schemes for the assessment of microbial load, genotyping and drug resistance.
In the past years PathoFinder has successfully participated in many EQA programs for both the MultiFinder, SmartFinder as well as the RealAccurate products.
Details of these tests are available on request.
We will keep participating in QCMD programs to ensure the quality, sensitivity and specificity our products.
