BDR’s commitment to regulatory compliance has led us to certify a Quality Management System (QMS) under the requirements of ISO 13485:2016 and the European Regulation 2017/746 on in vitro diagnostic medical devices.
BDR ensures the safety and proper performance of its products. To this end, both safety and performance studies of its products are carried out and these are subjected to a conformity assessment until EC Certification is obtained.
BDR carries out post-market surveillance processes (PMS) in order to collect the necessary data for product improvement and avoid possible problems as well as to establish reactive measures.
BDR is aware of the importance of the safety of the patients and end users of the products and works actively in the product vigilance system, collaborating with the competent health authorities and distributors to cover the whole supply chain. BDR is up to date with advances in the digitization of the information for medical devices and registers its products in the European EUDAMED database, which also contains the Summary Safety Performance (SSP) of the products.
Since 2011, the BDR´s QMS is certified according to EN ISO 13485. In 2021 it has been adapted and recertified to meet the requirements of IVDR 2017/746, Annex IX, Chapter 1 and 3. The QMS is constantly reviewed on its effectiveness through internal and external audits.
The scope of the certification includes the design, development, production and distribution of in vitro diagnostic products in the areas of immunology and genetics.
The QMS is based on a risk-based approach that allows the organization to identify factors that could generate deviations from the ISO 13485 standard and to implement preventive controls in order to minimize negative effects and better recognize market opportunities by anticipating trends.
BDR products fulfil the requirements of the Directive 98/79/EC on in vitro diagnostic medical devices and, also, they are in the process of certification under the new European Regulation 2017/746.
These certifications ensure that both the products and services meet all customers and regulatory requirements.
Declarations of conformity
BDR shows an integrated commitment in its strategy, policies and procedures to the values and ethical codes that arise from the relationships and transparent dialogue with its stakeholders, thus taking responsibility for the consequences and impacts of its actions.