Compliance frameworks, security audits, and quality certifications this company maintains.
Danaher's medical device and in vitro diagnostic manufacturing businesses — including Beckman Coulter, Cepheid, and Radiometer — maintain ISO 13485:2016 certification, ensuring that quality management systems for clinical analyzer design, manufacturing, and post-market surveillance meet global medical device quality requirements.
Danaher's life science instrument and bioprocessing manufacturing facilities globally maintain ISO 9001:2015 quality management certification, covering Cytiva bioreactor systems, Leica Microsystems optical instruments, and SCIEX mass spectrometry platforms.
Regulatory
FDA 21 CFR Part 820
CompliantDanaher's US-based IVD and medical device businesses, including Beckman Coulter Diagnostics and Cepheid, comply with FDA Quality System Regulation (21 CFR Part 820), governing design controls, manufacturing quality systems, and post-market surveillance for clinical laboratory instruments.
Regulatory
EU IVDR 2017/746
CompliantDanaher's Beckman Coulter Diagnostics and Cepheid have transitioned their European IVD portfolios to comply with EU In Vitro Diagnostic Regulation (IVDR) 2017/746, including updated performance evaluation reports, notified body certification for high-risk assays, and EUDAMED registration.
Regulatory
GMP 21 CFR Part 211
CompliantCytiva and Pall Life Sciences comply with FDA 21 CFR Part 211 cGMP requirements for components, containers, and closures used in biopharmaceutical drug manufacturing, as their single-use bioprocess systems are directly used in FDA-regulated drug production.
Environmental
ISO 14001:2015
CertifiedDanaher's major manufacturing sites maintain ISO 14001:2015 environmental management certification, supporting the company's sustainability commitments including a goal to reduce absolute Scope 1 and Scope 2 greenhouse gas emissions by 50% by 2035.
Danaher's cloud-connected instrument platforms — including Cepheid OnDemand, Beckman Coulter Remote Analytics, and Cytiva Bioprocess Cloud — are SOC 2 Type II certified, protecting customer laboratory and manufacturing data transmitted to Danaher cloud platforms.
Regulatory
CLIA Compliance
CompliantBeckman Coulter Diagnostics and Cepheid IVD systems sold in the US are cleared or approved under CLIA (Clinical Laboratory Improvement Amendments) for use in waived, moderate, and high-complexity laboratory settings, enabling placement across the full hospital laboratory continuum.
Regulatory
FCPA Compliance
CompliantDanaher operates a global Foreign Corrupt Practices Act compliance program governing its commercial relationships with government hospital customers, tender processes, and distributor arrangements in markets across Asia, the Middle East, and Latin America where public health system sales are common.
Environmental
REACH and RoHS
CompliantDanaher's laboratory instruments and analytical equipment sold in the European Union comply with REACH chemical substance restrictions and RoHS directives governing hazardous substances in electrical and electronic equipment, including Leica microscopes, SCIEX mass spectrometers, and Beckman Coulter analyzers.