Validation & Certification

Validation

The platelet counter PC100 is validated for 20-600 plt/nl, which covers about 90% of all applications. For platelet concentrations above 600 plt/nl another reagent dilution is required (validation for higher concentrations is pending). The validation is executed by Maastricht UMC+, Clinical Thrombosis & Hemostasis in the Netherlands.

Certification

The PC100 Platelet Counter is a device intended by the manufacturer to be used in vitro for the examination of blood derived from the human body, and matches the definition of ‘in vitro diagnostic medical device’, falling within the scope of IVDD 98/79/EC. The PC100 is CE IVD certified and complies with all Medical guidelines and regulations.

In Vitro Diagnostics Devices, non-Annex II List A and B in conformity with the Council Directive98/79/EC. In conformity with EN15223-1:2016, EN13612:2002, EN ISO18113-1:2011, EN ISO 18113-3:2011, EN61010-101:2002, EN61326-2-6:2006, EN62304:2006, EN 62366:2008 and 2011/65/EU.

To ensure full system quality, the PC100 Platelet Counter has been manufactured by Dutch Medical Devices BV in compliance with the requirements of applicable regulatory standards. DMD has a Quality Management System according to EN ISO 13485:2016+AC:2016.