Quality assurance and risk control are key pillars of MARLE GROUP culture, ensuring that every step of our production is monitored, validated, and meets the most stringent international requirements of the orthopaedic industry.
All of MARLE GROUP’s processes and activities meet or exceed the requirements of ISO 13485.
As our exclusive focus is on the manufacturing of orthopaedic devices, our Quality Management system has been expressly developed to concentrate on:
MARLE GROUP works exclusively with internally approved suppliers and has set up an exceptionally stringent quality control system for raw materials to ensure the reliability and efficiency of our group processes and to eliminate any potential product risks.
MARLE GROUP's quality system ensures complete product traceability, exhaustive documentation of all operations and associated checks, as well as thorough testing.
MARLE GROUP's global strategy aims to promote the commitment and autonomy of our operators as well as the continuous development of their skills. Each member of our team participates in ongoing vocational training adapted to their specific role. Our training programs address key topics such as product risk analysis, quality control, technical expertise and basic occupational skills.
Our investment strategy is designed to ensure we continue to meet our customers’ present and future requirements. It ensures our teams work with the latest production control systems and dedicated ISO 17025* accredited laboratories:
- Etablissements Maurice MARLE: Accreditation N° 1-2417
- ATS: Accreditation N° 1-6518
- SMB Medical: N° STS0619
Scope available on: www.cofrac.fr / www.sas.admin.ch
All of MARLE GROUP's processes have been validated, taking into account product risks and the requirements of applicable international standards:
MARLE GROUP also has several FDA-approved Master Files for the implementation of medical coating processes.
