CERTITUDE: The springboard for our quality approach
Since 1996, the PROTEOR Group has been committed to quality through ISO 9001 and ISO 13485 certification.
To reinforce its approach and guarantee the quality of its medical devices, PROTEOR launched the CERTITUDE quality commitment in 2023, based on 52 requirements divided into 6 key areas.
The safety of our patients is our priority and the foundation of our approach.
PROTEOR ensures the safety of its components and equipment through :
- Risk analysis.
- Implementing risk control measures from design to delivery.
- Guaranteeing the biocompatibility of materials and components according to their application.
- Regulatory compliance and CE marking of medical devices.
PROTEOR also conducts clinical studies as part of the design of its medical devices.
PROTEOR is committed to control the origin of its supplies and production:
- By monitoring the origin of our raw materials and components: 95% of our purchases are made from suppliers from France / EU / USA.
- Our components are designed and manufactured in our French or American industrial sites to promote local employment.
- 100% of our orthopedic devices are designed in the country where the orthopedic center is located.
PROTEOR is committed to control its sourcing through various measures:
- Rigorous selection of suppliers according to strict specifications.
- Annual evaluation of suppliers according to qualitative criteria.
PROTEOR is also committed to ethical purchasing, notably through :
- Setting up an ethics charter and a supplier code of conduct.
- Implementing supplier alert and monitoring systems to meet vigilance obligations.
PROTEOR allocates all its human and material resources to guarantee the quality of its components and equipment.
PROTEOR allowates all the expertise and know-how of its employees to deliver medical devices that comply with regulations and meet our customers’ needs.
- The manufacturing quality, by the appropriate infrastructure, the implementation of control procedures and conformity control, hygiene and integrity of our devices.
- Know-how through the management of our employees’ professional skills.
PROTEOR also develops and implements validated digital acquisition tools to optimize the management of patient input data.
Aligned with current regulations, PROTEOR guarantees the traceability of medical devices throught several aspects:
For our orthopedic components:
- Traceability of the device via serial/batch number management.
Traceability of design stages, controls on every stages of the medical device lifetime.
For our orthopedic devices:
- Traceability of patient files.
- Traceability of devices through unique identification.
- Traceability of the production stages and controls carried out throughout the process of acquiring and supplying the equipment.
PROTEOR puts all its resources at your disposal to guarantee optimum quality of service, in particular via :
- For our Components & Materials: via our after-sales service unit, available and ready to listen to you if you face any issues.
- For our Fittings: through our orthopedic centers network. Our teams are with you at each step (from the 1st appointment to delivery), and provide a follow-up care for your devices, including any alterations and interventions required to ensure safety and a proper fit.
Your satisfaction is our priority, and PROTEOR is always ready to listen to your questions and feedbacks to help us improve our components and services.
All our teams are committed to collect and analyze :
- Your level of satisfaction, via regular surveys.
- Your complaints and non-conformities reports, and we aim to respond as quickly as possible.
- Your feedbacks for improvement.