/ Validation of in vitro diagnostic methods and tools
Welcome to Amarok Biotechnologies, your trusted partner for accelerating and securing your development. As an analysis, test and research laboratory, we are pioneers in biotechnologies applied to in vitro diagnostics. We operate in the medical devices (IVD MD), food safety and environmental sectors, offering you customized support.
Opt for a maximum level of regulatory compliance for the validation of your medical biology machines and reagents (IVDR). Our laboratory is ISO 17025:2017 accredited for the evaluation of in vitro diagnostic medical devices (IVD MD).
Entrust your microbiological analyzes and your HACCP control to an independent laboratory in the countries of Saint-Malo and Dinan.
Outsource your research and development programs, benefit from support and advice for your R&D strategy:
• Hosting of research and development programs on behalf of third parties.
• Advice and support in the development of your research.
Control and analyze fermentations thanks to our innovations developed with our partner Q-Wine.
Benefit from our technical and scientific support for the use of rapid test kits and systems for agri-food and the environment Charm Sciences.
Specialists in evaluating the performance of in vitro diagnostic medical devices (IVD MD) before they are placed on the market, we are also the first French laboratory accredited ISO 17025:2017, for this type of activity. With us, you will have the best guarantee of compliance with the requirements of the new European regulation 2017/746 (IVDR) or the regulatory authorities.
We are the first in the world to have developed and marketed an immuno-cytometric method for diagnosing fermentation contamination for the wine industry. Our Brettanomyces yeast detection test remains unique internationally.
We are the representative in France of Charm Sciences Inc, the world leader in rapid tests for the detection of antibiotic residues in milk and for the safety of food production processes.
We have developed a solid institutional, associative and private partnership network, both locally and internationally.BPI, Brittany Region, European Enterprise Network
Our services are aimed at IVD manufacturers and, more broadly, all players in the in vitro diagnostics sector (importers, distributors, regulatory affairs or quality management professionals). We provide expert performance evaluations (ISO 2017/746) for IVDs. We also deliver solid, personalized R&D support for laboratories and innovative startups.
Restaurants and caterers find in our analytical laboratory tailor-made answers to their needs to guarantee food safety. We carry out hygiene checks and food analyses, and advise on regulatory issues.
For aquaculturists (crustaceans, mollusks, etc.) and shellfish farmers (oysters, mussels, clams, etc.), we offer customized microbiological control solutions. Seafood products must meet some of the most stringent quality and safety standards.
We support the wine industry - winery owners, technical departments and wine analysis laboratories - in very specific ways to guarantee premium product quality. We are constantly innovating to improve control performance and process monitoring.
The food industry, and more specifically the dairy and cereal sectors, benefit from our sales and technical support for Charm Sciences products. As the brand's sole representative in France, we help them to select and use rapid test kits and equipment for controlling food contaminants.
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Would you like to request a quote or discuss your projects?
Would you like to request a quote or discuss your projects?
Validation of in vitro diagnostic methods and tools