Quality - Technologie Médicale

TM’s Quality Commitment

TECHNOLOGIE MEDICALE has implemented a certified quality management system.

CE Marking: A Guarantee of Compliance and Quality

The medical devices manufactured by TECHNOLOGIE MEDICALE comply with the regulatory (and normative) requirements related to medical devices. This compliance is verified annually by LNE/G-MED, the French notified body.

Accordingly, all TECHNOLOGIE MEDICALE products bear the CE marking, certifying their compliance with European regulatory requirements regarding safety, performance, and quality.

ISO 13485

Furthermore, TECHNOLOGIE MEDICALE’s quality management system is certified to ISO 13485:2016, the international standard specifically applicable to medical devices. This certification attests to the high level of rigour applied across all processes of design, manufacturing, and post-market surveillance.

SNITEM

As a committed player in its market, TECHNOLOGIE MEDICALE is a member of SNITEM (French National Association of the Medical Technology Industry), the leading professional association for the sector in France.

Inspection

To ensure the proper functioning of each medical device we manufacture, we perform individual testing in our workshops before shipment. This systematic inspection, using measuring equipment under metrological control, reflects our high standards of quality and reliability.

Traceability

Each medical device is identified by a unique serial number, ensuring complete traceability — from manufacturing to delivery, and throughout its entire life cycle. This precise tracking reinforces the safety and trust in our products.

Reliability

Thanks to rigorous internal procedures, we ensure the reliability of our medical devices and contribute to the long-term satisfaction of our customers.