CAP-, CLIA- and DIN EN ISO 15189:2014-accredited, and GLP-certified, our lab conducts clinical trials in full compliance with EMA, FDA and GCLP guidelines. Sample handling and analytical procedures are entirely conducted by qualified personnel.
We record all data in our laboratory information management system (LIMS), ensuring seamless tracking from sample receipt through analysis to final report generation.
The performance of our analytical methods is constantly monitored by internal and external quality controls. The laboratory participates regularly in proficiency tests with:
- RfB: Referenzinstitut für Bioanalytik
- INSTAND: Institut für Standardisierung und Dokumentation
- CAP: College of the American Pathologists
- NGSP: National Glycohemoglobin Standardization Program
We are certified by NGSP as level I laboratory.
Our quality certificates can be downloaded here:
- MLM_CLIA_Accreditation_2021_full.pdf (747.12 KB)
- List_of_Test_Procedures_within_the_flexible_scope_of_the_ISO_15189_accreditation_May_2021.pdf (203.59 KB)
- ISO_15189_2014_Certificate_MLM_2021.pdf (6.82 MB)
- Statement_of_GLP_Compliance_MLM_2018.pdf (1.09 MB)
- MLM_CAP_Certificate.pdf (171.57 KB)
- Continuation_CAP_Accreditation_Letter.pdf (78.88 KB)
- NGSP_2021.pdf (1.14 MB)
- MLM BVMA Audit Certificate 2019 (894.22 KB)