Quality FAQ

A quality management system (QMS) is the set of processes, procedures, responsibilities and controls put in place to ensure that medical devices meet the applicable regulatory requirements as well as the expectations of healthcare professionals and patients.
The QMS covers the entire product lifecycle, from design through to post-market surveillance. Its aim is to ensure the safety, performance and compliance of medical devices whilst promoting continuous improvement.
Vygon is continuing to harmonise its quality management systems across the Group in order to strengthen the consistency of its practices, promote the sharing of best practice and support the continuous improvement of its operations.

Before being placed on the market, a medical device undergoes numerous assessments and checks designed to demonstrate its safety, performance and compliance with the applicable regulatory requirements.
Depending on its nature, intended use and risk class, these assessments may include, in particular:

• performance tests;
• biocompatibility assessments;
• validation of manufacturing processes;
• sterilisation validation for devices claimed to be sterile;
• clinical evaluations;

• verification that the technical documentation complies with the applicable regulatory requirements.

  
  For devices presenting a moderate to high level of risk, these elements are also examined by an independent notified body as part of the CE marking process.
  These checks aim to demonstrate that the device meets the applicable safety and performance requirements prior to being placed on the market.

The CE marking indicates that a medical device complies with the requirements of the applicable European regulation regarding safety and performance.
Before the CE marking is granted, the manufacturer must demonstrate that the device meets these requirements through assessments, tests and appropriate technical documentation. For most medical devices, this assessment is also carried out by an independent notified body.
The CE marking authorises the device to be placed on the market within the European Union.

Vygon medical devices are manufactured using processes that are defined, validated and monitored in accordance with the applicable regulatory requirements. Vygon relies on an international industrial network comprising 11 production sites, eight of which are located in Europe, which manufacture medical devices for healthcare professionals in over 120 countries. Throughout the manufacturing process, checks are carried out on raw materials, components, equipment and finished products. Documented inspections, tests and checks confirm that products comply with requirements before they are made available to users. Our production sites apply harmonised quality requirements and are subject to regular audits to verify the effectiveness of processes and compliance with applicable regulatory requirements.
Quality is taken into account at every stage of the manufacturing cycle, with one constant objective: to provide safe, high-performing medical devices that meet the expectations of healthcare professionals and patients.

When a non-conformity is identified, it is analysed to understand its cause, assess its potential consequences and determine the appropriate actions. Depending on the situation, corrective or preventive actions may be implemented, such as additional checks, process changes, training initiatives or other measures designed to prevent recurrence. The aim is to deal with the situation appropriately, prevent it from recurring and contribute to the continuous improvement of product quality and safety.

Post-market surveillance, also known as Post-Market Surveillance (PMS), involves monitoring the performance and safety of medical devices once they are in use under real-world conditions.
It enables the collection and analysis of information from various sources in order to identify trends, opportunities for improvement or, where necessary, actions to be taken.
Post-market surveillance is a fundamental requirement of medical device regulation.

Feedback may come from healthcare professionals, healthcare organisations, distributors, partners or competent authorities.
Each report is recorded, analysed and processed in accordance with defined procedures. The information collected contributes to the continuous improvement of products, processes and patient safety. This feedback is an important source of information for the quality management system.
 

A batch recall is a measure taken when a specific product or a set of identified products requires specific action after it has been placed on the market. Depending on the nature of the situation, the recall may lead to the return, exchange, modification or withdrawal of the products concerned. Recalls are carried out in accordance with established procedures and in coordination with the competent authorities.

Not necessarily. Recalls may be initiated for various reasons, ranging from an administrative or labelling discrepancy to a more significant potential risk. Each situation is subject to a specific assessment. The decision to issue a recall demonstrates, above all, that the surveillance, vigilance and risk management mechanisms are functioning in accordance with regulatory requirements.

Vygon collaborates transparently with the relevant authorities in all countries where its products are marketed. This collaboration includes, in particular, regulatory exchanges, vigilance activities, required reporting, inspections, audits and, where necessary, the implementation of safety measures. The aim of these exchanges is to contribute to the safety of patients and users and to ensure compliance with applicable regulatory requirements.

Yes. Like all medical device manufacturers, Vygon is regularly audited and inspected by notified bodies and by the competent authorities. These assessments verify compliance with applicable regulatory requirements, the effectiveness of the quality system and control over manufacturing processes. These assessments form part of the standard supervisory framework applicable to medical device manufacturers.
In particular, Vygon undergoes regular surveillance audits carried out by its notified body as part of the process of maintaining its CE certifications and markings. The competent authorities may also carry out inspections on their own initiative, in accordance with their surveillance programme or when a specific situation warrants it.

Recalls form part of the normal operation of the medical device vigilance system. They may be implemented when an assessment concludes that action is necessary to maintain a high level of safety, compliance or performance. The existence of recall procedures is an essential component of responsible risk management.

When a safety action is decided upon, the customers, distributors or establishments concerned are informed in accordance with the applicable regulatory procedures. The information provided specifies the products concerned, the expected measures and the procedures for following up on the action. The competent authorities may also make certain information public when they deem it necessary.

Safety corrective actions and recalls form part of the mechanisms provided for under the regulations governing medical devices.
They ensure continuous monitoring of products throughout their life cycle and contribute to the protection of patients and users.
In a highly regulated environment, the rapid detection and resolution of situations requiring action are an integral part of the quality management system.

If you wish to report an incident, a complaint or any concern regarding a Vygon product, please contact your usual Vygon representative. Every report is recorded and analysed in accordance with the applicable procedures to ensure that the information received is dealt with appropriately.