In immunohaematology, enhanced safety and performance research is an essential requirement. DIAGAST mobilizes to listen to the market, pre-empt its needs and respond to new regulations in terms of Quality and Safety. Our solutions meet the new regulations and quality standards applicable in France and abroad.
Thus, from their design stage until their installation and after-sales service, they are subject to strict compliance with the quality management system specific to in vitro diagnosis medical devices (IVDMD).
Our belief is to constantly aim for excellence in customer satisfaction in total coherence with the company’s values and the new regulations in terms of Quality and Safety. This is carried out through 3 axes:
- Products of the highest quality,
- A seamless service to our customers and partners,
- A dynamic and agile quality management to inscribe DIAGAST in a continuous improvement process of our products and processes.
All of DIAGAST’s collaborators actively participate in these 3 principles through a daily commitment, an active transversal cooperation and a permanent exchange with the customers (internal or external).
This commitment goes hand in hand with a constant search for economic performance for our customers and for DIAGAST. But it also requires an optimal qualification of all our collaborators in their respective roles and a continuous training to increase their business performance or to acquire new skills.
History of certifications (international and national)
1997: ISO 9001 NF certification
2003: CE marking and ISO 13485 NF certification
2008: First US FDA approval
2012: GMP ANVISA certification (Brazilian Health Surveillance Agency) and GMP KFDA certification (South Korean Health Surveillance Agency)
2018: Renewall of the NF EN ISO 13485 :2016 certification for our Quality Management System and EC marking and MDSAP certification for Canada, Brazil and Australia.
2019 : Certification by the GMED of the new industrial premise for CE devices.
2020 : Renewal of the US FDA approval for DIAGAST head office and PMC approval from the US FDA for the industrial premise.
Quality Assurance and Quality Control
The quality of our products and services is a daily commitment from each employee and is measured through quality indicators. Quality Assurance establishes and develops the general provisions to be made to control our processes, manage risks and drive the continuous improvement of our organisation, infrastructures and practices.
These provisions, grouped under the term Quality Management System, meet very strict international regulatory requirements.
In accordance with established specifications, quality inspections are performed at each production stage, from raw materials to in-process inspections and finished products. The traceability of each production is achieved by the use of a batch record. Each batch record as well as the conformity of the quality inspections are checked by the quality department in order to authorize the release for sale of the batches.
New IVDR regulation objective: the priority issue for the Clinical Affairs Department
The Regulatory Affairs department has been transformed to increase the prerogatives of the teams in charge of product validations: this is how the Clinical Affairs Department was born.
While keeping the responsibility of new DIAGAST projects in support with R&D, the department is also responsible for ensuring the compliance of all our reagents with the new European Regulation IVDR 2017/746 EU.
For this purpose, a manager and several laboratory technicians were hired to carry out the missing studies, but also to strengthen the management of this project.
Following this new European Regulation, the service is obliged to generate new validation data, to establish new procedures and to strengthen international partnerships with defined and controlled obligations.It also introduces more and more obligations with one central pillar: the assurance of safe, high-performance devices and reagents throughout their lifetime, guaranteeing excellent service to users and patients.
DIAGAST must provide the patient with a safe and effective device. We must know, control the risks and reassess the Benefit / Risk balance at all times.
At DIAGAST, we are demanding on ourselves to meet this new European regulation, and any other applicable in an international export context. This is all the more important because Europe is the state of the art for health products, to the point that more and more countries are requiring CE marking. In addition, new international standards and regulations are no longer based just on FDA requirements, but also on European requirements.
(*) The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new European Union legislation, applicable to in vitro diagnostic medical devices (IVDD). Entering into force on May 25, 2017 and marking the beginning of a five-year transition period for manufacturers and economic operators, the IVDR replaces the European In Vitro Diagnostic Directive (IVDD) 98/79/EC.
