Quality and certifications – Our commitment to reliable, safe, and recognized genomics services
At GenoScreen, quality is not an option; it is a requirement. Since its inception, our company has made compliance with the strictest standards a pillar of its strategy. Our services and products in genomics, molecular microbiology, and bioinformatics are governed by a robust quality management system, recognized at both the national and international levels.
Certified quality to ensure reliability, compliance, and customer satisfaction
We are committed to providing services and products that are:
High-quality, reliable, and high-performance
Compliant with regulations
Tailored to the requirements of clinical laboratories, research centers, industrial players, and public institutions
Our quality approach is based on:
Continuous improvement of our internal processes
Active listening to our customers
Technological innovation at the service of performance
Adaptability to regulatory and scientific developments
Our quality objectives
Our quality commitments are clear and concrete:
Offering innovative and reliable services
Continuously improving our processes
Ensuring the long-term satisfaction of our customers
Complying with national and international standards
Adapting our services to the specific needs of each customer
Our certifications
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ISO 13485:2016 Certification – Quality Management Systems for Medical Devices
Certification date: October 31, 2025
Expiration date: November 7, 2027
GenoScreen holds ISO 13485:2016 certification for the design, development, manufacture, marketing, and distribution of in vitro diagnostic kits.
This certification guarantees the safety, quality, and traceability of our medical devices, meeting international regulatory standards (Europe, FDA, and beyond).
ISO 9001:2015 Certification – Quality management system for all products and services
Certification date: October 31, 2025
Expiration date: November 7, 2027
Our ISO 9001:2015 certification confirms the quality of all our activities: • Design and development of genomic solutions
• Sequencing and analysis services
• Scientific training and expertise
It applies across all our service divisions and ensures controlled, fully documented processes.
GenoScreen applies Good Clinical Laboratory Practice (GCLP) standards to ensure rigorous and compliant analysis of samples in clinical trials.
This ensures:
• Compliance with GCLP standards
• The quality, reliability, and integrity of clinical data produced
• Protection of patient confidentiality and rights
Our regulatory compliance
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Compliance with national and international regulations
Protective measures against plant pests (EU Regulation 2016/2031, 26 October 2016)
Our authorization, formalized by a prefectural decree, covers the receipt and handling of soil samples from non-EU countries in accordance with the derogatory measures of EU Regulation 2019/829. The authorization was issued by the Regional Directorate for Food, Agriculture and Forestry (DRAAF), Plant Health Service.
Directive 2009/41/EC and Decree No. 2011-1177 on the contained use of genetically modified organisms
Expiration date: December 18, 2029
Our authorization covers the possession and use of Class 1 genetically modified organisms (GMOs) for research, development, or educational purposes, in accordance with Article L.532-3 of the Environmental Code.
Authorization for highly pathogenic microorganisms and toxins
Expiration date: December 18, 2029
GenoScreen is authorized by the French National Agency for Medicines and Health Products Safety (ANSM) for the possession, handling, and use of highly pathogenic microorganisms and toxins (HPT). This authorization ensures the safe management of HPTs and full traceability of their handling and transfer.
HPT Accreditation (Highly Pathogenic Microorganisms and Toxins) from ANSM (valid until 21/03/2030): Authorization for the possession, acquisition, handling, and use of HPTs in accordance with Decree No. 2010-736 of 30 June 2010 on microorganisms and toxins (list defined in Article L5139-1 of the French Public Health Code
, as specified by the Order of April 26, 2023).
Other recognitions and accreditations
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Further recognitions and certifications
Crédit Impôt Recherche
GenoScreen is CIR program-accredited for the 2025–2029 period, reflecting the high quality of its research and development (R&D) activities in genomics and bioinformatics.
Oxford Nanopore Technologies Certified Service Provider
We are a certified service center for Oxford Nanopore (GridION) long-read sequencing technology, ensuring:
• High-quality analyses
• Advanced technical expertise
• Personalized support for your long-read sequencing projects
Frequently asked questions
Which quality certifications does GenoScreen hold?
GenoScreen is ISO 9001:2015 certified for all its activities in genomics, bioinformatics, and molecular microbiology, and ISO 13485:2016 certified for the design and production of in vitro diagnostic kits. It also applies GCLP principles to its activities related to clinical trials.
Why is ISO 13485 certification important?
ISO 13485 certification ensures that the medical devices produced by GenoScreen comply with strict quality, safety, and regulatory standards. It is essential for the European and international markets.
Is GenoScreen authorized to handle pathogenic microorganisms?
Yes, GenoScreen holds a MOT authorization issued by the ANSM, allowing it to possess, use, and exchange highly pathogenic microorganisms and toxins under strictly controlled conditions.
Are GenoScreen’s services suitable for clinical trials?
Yes, GenoScreen follows Good Clinical Laboratory Practice (GCLP) to ensure the quality, integrity, and traceability of analyses performed as part of clinical trials.
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