Quality at the heart of our mission
For over 60 years, Vygon has been supporting healthcare professionals with a firm conviction: quality and patient safety must guide every decision we make. As a family-owned company with French roots, we design, manufacture and distribute medical devices designed to meet the needs of healthcare professionals and patients, particularly in the field of critical care.
Our ambition is to help save lives by providing safe, high-performing and innovative medical devices, whilst building a lasting relationship of trust with the healthcare professionals who use them on a daily basis.
A shared responsibility
At Vygon, quality is not solely the responsibility of the Quality teams. It relies on the commitment of all our staff at every stage of our products’ lifecycle: design, development, manufacture, inspection, distribution and post-market surveillance.
This collective approach has a single aim: to ensure that our medical devices meet the applicable regulatory requirements and users’ expectations, whilst safeguarding patient safety.
Industrial expertise in the service of quality
Vygon draws on an international industrial network comprising 11 production sites, eight of which are located in Europe, as well as teams specialising in quality, regulatory affairs, engineering, manufacturing and vigilance.
Vygon’s quality system is implemented in accordance with the international standards applicable to medical devices, notably ISO 13485, Regulation (EU) 2017/745 (MDR), the requirements of the US FDA (21 CFR Part 820) and the local regulations of the markets in which the Group operates. This organisation aims to ensure long-term regulatory compliance, rigorous risk management, effective post-market surveillance of products, and adherence to the safety and performance requirements expected by patients, healthcare professionals and the competent authorities.
To ensure the consistent application of these requirements across all its operations, Vygon implements harmonised processes Group-wide.
Regular checks, performance indicators and internal and external audits help to verify the effectiveness of these processes, maintain high standards and support the continuous improvement of our practices.
An approach based on continuous improvement
Quality is a dynamic process. User feedback, regulatory changes, scientific advances and the analysis of our own performance constantly help to drive the improvement of our products and processes.
This approach is fully aligned with our United Vysion strategic plan, which places the company’s sustainable development, operational excellence, regulatory compliance and continuous improvement at the heart of our priorities.
Our commitment
Our commitment is simple: to act with integrity, to fully accept our responsibilities and to do everything in our power to provide healthcare professionals with medical devices that meet the highest standards of quality, safety and performance.
Because behind every medical device, there is a healthcare professional, an act of care and a patient.
“Our core business: to provide safe, high-performing and innovative medical devices to support healthcare professionals and help save lives.”
