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Firalis
  • About
    • Group CEO
    • Management Team
    • Supervisory Board
    • Scientific Advisory Board
    • Affiliates
    • R&D Partnerships
    • Distributors
    • Quality Standards
    • Careers
    • Location
  • Products
    • MEMORYLINC
    • NEUROLINCS
    • FIMICS
    • ELISA Kits
    • Recombinant Proteins
    • Monoclonal Abodies
    • Clinical Samples
  • R&D
  • Quality
  • Media
    • Press Releases
    • Media News
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at Firalis, all services are performed under certifications of the
HIGHEST INDUSTRY STANDARDS
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    ISO 9001:2015

    Worldwide reference standard for Quality Systems Management

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    ISO 13485:2016

    Quality Management System for the Design & Manufacture of Medical Devices

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    ISO 14001:2015

    Development, Production and Sales of IVD tests, Storage & Analysis of biological and environmental samples

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    GCLP

    Compliance for Good Clinical Laboratory Practice

  • click on the boxes above to view the associated Quality certificate

    QUALITY VALUES of Firalis :                                                                                                    

     

    > Responsibility : We set precise roles and functions to prevent and ban conflict of interest.

    > Qualification : We train and coach our employees to develop competences and keep up with the best practices.

    > Customer Focus : We challenge our customers for utmost clarity and ensure strict confidentiality of all client data.

    > Standardization : We perform all work according to written procedures regularly monitored and updated.

    > Traceability : We keep a full audit trail of responsibilities and actions at all stages of service/production processes.

     

    QUALITY STANDARDS of Firalis :                                                                                             

     

    > ISO 9001

    ISO 9001:2015 sets out the criteria and the structure of a quality management system and is implemented by over a million companies and organizations in over 170 countries and is the worldwide reference for the management of quality systems.

    View Firalis' certificate here

     

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    > ISO 13485

    ISO 13485 sets all requirements of a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 is harmonized with requirements set by the European medical device directives 93/42/EEC and 98/79/EC.

    Subject certificate is valid and covers the following activities :

    -Development, Manufacturing and Placing on the Market of Immuno-assays and Nucleic Acid Detection in Vitro Diagnostic Devices in the Frame of Cardiac, Neurodegeneratives, Immuno-inflammatory and Infectious Diseases.

    -Development, Production and Sales of Immuno-assays and Nucleic Acid Detection in Vitro Diagnostic Devices for Research Purposes

    -Development, production and sales of intermediate and derived products, antibodies and proteins for research purposes

    View Firalis' certificate here

     

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    > ISO 14001 : 2015

    ISO 14001 : 2015 sets all requirements of a comprehensive quality management system for the development, production and sales of in vitro diagnistic tests (immuno-assays and nucleic acid detection tests) as well as the storage and analysis of biological and environemental samples.

    View Firalis' certificate here

     

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    > Compliance for Good Clinical Laboratory Practice (GCLP)

    To answer sponsors' needs to outsource analysis of biomarker samples (to a GCLP supplier), Firalis established processes compliant with the GCLP guidelines (EMA/INS/GCP/532137/2010, Feb 2012; WHO Good Clinical Laboratory Practice, 2009).

     

    For more information, contact Firalis' Quality Team !

     

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