We are committed to offering products and services that meet all the guarantees of quality, efficiency and sustainability, which is why we have undergone a process of evaluation by the National Accreditation Entity (ENAC), in which we have obtained certificates of compliance with the requirements of the three standards:
- Services and processes, through the ISO 9001:2015 standard.
- Medical devices, through the UNE-EN ISO 13485:2016 standard.
- The security of the information we handle, through the UNE-ISO/IEC 27001:2014 standard.
A great challenge that we have achieved thanks to the effort and commitment of our team.
The Directive 98/79/EC of the European Parliament constitutes the European Union regulatory framework for in vitro diagnostic medical devices. This Regulation aims to ensure the proper functioning of the internal market for in vitro diagnostic medical devices, based on a high level of health protection for patients and users and taking into account the interests of small and medium-sized enterprises active in this sector.
We develop bioinformatics products and services for the analysis and interpretation of genomic data from Next-generation Sequencing (NGS) technologies. Our products include the Genome one software and the Genome one Reports web viewer.
Genome one, and all the analyses carried out with it, comply with the necessary requirements regarding the CE marking of medical devices for In Vitro Diagnostics (IVD) in accordance with current legislation (Licence Number: 7157-PS). The CE mark certifies that the analyses carried out with Genome one are among the most reliable on the market.
Innovative Technology-Based Company
The Technology-Based Innovative Company (EIBT) label implies the intensive mastery of knowledge and the exploitation of research results that involve a technological advance in obtaining new products, processes or services, or the substantial improvement of existing ones. It is awarded to companies that operate in sectors known as “high technology” and that have scientific or highly qualified personnel at a technical level.
Dreamgenics S.L. has been recognised by the National Association of Spanish CEEIs (ANCES) as an EIBT. This recognition has the backing of the Ministry of Industry, Tourism and Trade, and offers guarantees to demonstrate Dreamgenics’ potential as a top-level innovative project to different investment agents, grant granting institutions or potential partners.