Global therapeutic solutions in ophthalmology
Our quality policy is based around three key directions:
- Customer satisfaction
- Continuous improvement
Requirements targeting our business area:
- Legal requirements:
The medical devices market is a tightly regulated sector at both international, European and national levels. The Quality Department is in charge of Quantel Medical Regulatory Affairs.
- CE marking:
- At product level:
CE marking according to European directive 93/42 is a regulatory requirement for any business seeking to market a medical device on the European Market. This European regulation mainly concerns safety requirements for people and performance requirements for equipment, throughout the equipment's lifetime. This European directive was incorporated into French law by Decree No. 95-292. All Quantel Medical products sold in France carry the CE mark in accordance with this European directive.
Find out more: www.legifrance.gouv.fr
- At service level:
The maintenance and quality control requirement covering medical devices is specified in Decree No. 2001-1154 dated 5 December 2001. This decree sets out the new responsibilities for operators regarding the management of the relevant medical devices.
All Quantel Medical development and manufacturing centers are certified to ISO 9001 and ISO 13485.
ISO 9001 - ISO 13485 (pdf)
- Managing anomalies:
- Managing product anomalies:
This operating mode allows for integrating global feedback on Quantel Medical products, making decisions on upgrade options and guaranteeing consistent performance over the whole installed equipment base on a worldwide scale.
- Protection of patients and users:
This is ensured through compliance with the harmonized standards governing the use of our products.
- Protection of the environment:
By factoring recycling concerns into our product solutions right from the development stage.
By recovering and reprocessing electronic waste.
Our customers expect our products to deliver high environmental performance and our business activities to demonstrate ecological responsibility. Our efforts in this area are primarily focused on pollution prevention. Therefore, all the new equipment we put out onto the market is designed to be less polluting (in compliance with the DEEE and ROHS directives) and to significantly reduce employee and patient exposure to Ultrasounds and laser beams.
- Managing product-related risks:
Should anyone identify a safety issue or a case of non-compliance with the specifications, Quantel Medical agrees to notify the user and upgrade the equipment as required, at its own expense and in the shortest possible time, throughout the equipment's life time.
Quantel Medical provides a warranty on all new equipment in order to prevent any such incident.
To ensure correct operation of all equipment, Quantel Medical has set up a real-time monitoring system covering the various equipment together with a policy designed to ensure the availability of spare parts during a minimum period. A copy of this policy is addressed to the customer.
- Materials vigilance:
Materials vigilance is designed to monitor incidents or risks of incidents that may arise due to use of the medical devices following market launch. Information on any anomaly identified by our personnel or reported by our customers is automatically forwarded to the competent French authority designated by the market surveillance body, ANSM (Agence Nationale de sécurité du médicament et des produits de santé).