Certifications
BDR, in its commitment to regulatory compliance, has certified a quality management system under the requirements of the ISO 13485:2016 standard and the European Regulation 2017/746 on in vitro diagnostic medical devices.
ISO Certificate
Blackhills Diagnostic Resources has a Quality Management System certified under ISO 13485:2016, adapted to meet the requirements of Regulation 2017/746 (IVDR). This system is based on a risk-based approach that enables the organization to identify factors that could cause deviations and apply both preventive and corrective controls to minimize negative effects.
The scope of the certification includes the design, development, production, and distribution of in vitro diagnostic products in the fields of immunology and genetics.
EC Certificates
BDR products comply with the requirements of European Regulation 2017/746 on in vitro diagnostic medical devices. Compared to the IVDD, the IVDR involves more rigorous oversight by competent authorities and notified bodies, as well as more extensive performance evaluations by the manufacturer.
Some BDR products are still manufactured in accordance with the requirements of Directive 98/79/EC on in vitro diagnostic medical devices. The transition to IVDR is gradual.
Both certifications ensure product quality and regulatory compliance.
RSA
BDR demonstrates a commitment integrated into its strategy, policies, and procedures with values and ethical codes that stem from relationships and transparent dialogue with its stakeholders, thus taking responsibility for the consequences and impacts of its actions.
The RSA (Responsabilidad Social de Aragón) Seal, awarded by the Government of Aragón, certifies this commitment, recognizing BDR as a socially responsible company that meets high ethical standards in areas such as sustainability, equality, and community support.
