IMPACT is developed and supplied by Hart Biologicals, committed to meeting the highest standards in the industry using ISO 13485 driven quality systems.
Everything you need to install, operate and stay compliant with IMPACT - from the Operator's Manual to regulatory statements - is available to download below.
Installation, operation, maintenance and troubleshooting for the IMPACT instrument (Research Use Only)
Download manualHart Biologicals operates an ISO 13485:2016 certified quality management system covering the design, manufacture and supply of in vitro testing components.
The IMPACT instrument is currently supplied for Research Use Only (RUO) and is not for use in diagnostic procedures.
Certified quality management system
Quality System Regulation compliance
Country-specific requirements for Australia, Canada and the USA
Transition from the IVD Directive (IVDD) in progress
Our products are assessed under REACH (EC) No. 1907/2006 and the CLP Regulation (EC) No. 1272/2008. Where a product is classified as hazardous, a Safety Data Sheet is available on request.
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