Quality Policy

Quality Policy

Dreamgenics is a Spanish biotechnology company formed by a multidisciplinary team of clinicians, scientists and computer scientists with extensive experience in genomics, proteomics and bioinformatics. A fundamental part of our activity in the field of bioinformatics is the development of bioinformatics products and services for the analysis and interpretation of genomic data from new generation sequencing technologies (NGS). Among our products we have the Genome one genomic analysis software platform. This software, as well as all the analyzes 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.

 

Within our scope of daily work we carry out genomic studies (genomes, exomes, gene panels, etc.), transcriptomics and metagenomics of data from NGS technologies for different diseases. In addition, our services include pre-project development advice, nucleic acid isolation sample processing, sequencing, and data analysis and exploitation.

 

Our mission

 

Make genomic, proteomic and bioinformatic solutions available to clinicians and researchers that help to decipher the molecular bases of diseases.

 

 Our vision

 

Each of us who are part of Dreamgenics are proud to be able to contribute to the of Precision Medicine development and our desire is to continue improving every day to continue helping to improve people’s quality of life.

 

The pillars on which Dreamgenics is based are fundamentally:

  • Support research groups and doctors of international prestige.
  • Wide experience, solidity and scientific base, in addition to a deep knowledge of the technological market.
  • The medical devices for in vitro diagnosis and services provided to our clients obtain quality, clear and fast results that allow a simple and intuitive interpretation of the genome with a very close to clinical and research language.
  • Compliance with applicable legal and business requirements regarding health products, information security and information systems.
  • The assurance of the confidentiality of the information that our stakeholders deposit and that Dreamgenics stores in its information systems.
  • The achievement of excellent working conditions and environment that allow a high satisfaction of the Dreamgenics multidisciplinary work team.
  • Improving the quality of healthcare products and services provided by analyzing data and identifying areas for improvement, collaborating jointly with the involved stakeholders.

 

We pursue a continuous improvement of our processes and the maintenance of a Technological Management System in accordance with the requirements established by the UNE-EN ISO 9001 standard (Quality management systems, requirements), the UNE-EN ISO 13485 standard (Medical devices, Quality management systems, requirements for regulatory purposes) and the UNE-ISO / IEC 27001 standard (Information security management systems, requirements), whose is defined as “The provision of the bioinformatics analysis service of data from the sequencing of genomic material for clinical and research”,”The design and development of software for bioinformatic analysis services of data from the sequencing of genomic material “(based on ISO 9001),”The software design and development for bioinformatic analysis services of data from the sequencing of genomic material for the in vitro diagnosis of genetically based human diseases”(ISO 13485) and “The information systems that support the services of: – design and development, marketing and maintenance of software and services – provision of bioinformatic analysis services of data from DNA sequencing according to the declaration of applicability in force on the date of issuance of the certificate ”(based on ISO / IEC 27001).

 

This policy is reviewed at least once a year in order to verify its adequacy to the actual way of acting of the Company, as well as to the context in which it provides its services and provides the frame of reference to establish quality objectives and information security.

 

In order to be known, it is disseminated to the staff and is publicly displayed on our website.

 

Last modification: June 25, 2021

Quality Policy

Dreamgenics is a Spanish biotechnology company formed by a multidisciplinary team of clinicians, scientists and computer scientists with extensive experience in genomics, proteomics and bioinformatics. A fundamental part of our activity in the field of bioinformatics is the development of bioinformatics products and services for the analysis and interpretation of genomic data from new generation sequencing technologies (NGS). Among our products we have the Genome one genomic analysis software platform. This software, as well as all the analyzes 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.

 

Within our scope of daily work we carry out genomic studies (genomes, exomes, gene panels, etc.), transcriptomics and metagenomics of data from NGS technologies for different diseases. In addition, our services include pre-project development advice, nucleic acid isolation sample processing, sequencing, and data analysis and exploitation.

 

Our mission

 

Make genomic, proteomic and bioinformatic solutions available to clinicians and researchers that help to decipher the molecular bases of diseases.

 

 Our vision

 

Each of us who are part of Dreamgenics are proud to be able to contribute to the of Precision Medicine development and our desire is to continue improving every day to continue helping to improve people’s quality of life.

 

The pillars on which Dreamgenics is based are fundamentally:

  • Support research groups and doctors of international prestige.
  • Wide experience, solidity and scientific base, in addition to a deep knowledge of the technological market.
  • The medical devices for in vitro diagnosis and services provided to our clients obtain quality, clear and fast results that allow a simple and intuitive interpretation of the genome with a very close to clinical and research language.
  • Compliance with applicable legal and business requirements regarding health products, information security and information systems.
  • The assurance of the confidentiality of the information that our stakeholders deposit and that Dreamgenics stores in its information systems.
  • The achievement of excellent working conditions and environment that allow a high satisfaction of the Dreamgenics multidisciplinary work team.
  • Improving the quality of healthcare products and services provided by analyzing data and identifying areas for improvement, collaborating jointly with the involved stakeholders.

 

We pursue a continuous improvement of our processes and the maintenance of a Technological Management System in accordance with the requirements established by the UNE-EN ISO 9001 standard (Quality management systems, requirements), the UNE-EN ISO 13485 standard (Medical devices, Quality management systems, requirements for regulatory purposes) and the UNE-ISO / IEC 27001 standard (Information security management systems, requirements), whose is defined as “The provision of the bioinformatics analysis service of data from the sequencing of genomic material for clinical and research”,”The design and development of software for bioinformatic analysis services of data from the sequencing of genomic material “(based on ISO 9001),”The software design and development for bioinformatic analysis services of data from the sequencing of genomic material for the in vitro diagnosis of genetically based human diseases”(ISO 13485) and “The information systems that support the services of: – design and development, marketing and maintenance of software and services – provision of bioinformatic analysis services of data from DNA sequencing according to the declaration of applicability in force on the date of issuance of the certificate ”(based on ISO / IEC 27001).

 

This policy is reviewed at least once a year in order to verify its adequacy to the actual way of acting of the Company, as well as to the context in which it provides its services and provides the frame of reference to establish quality objectives and information security.

 

In order to be known, it is disseminated to the staff and is publicly displayed on our website.

 

Last modification: June 25, 2021

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