Focused quality assurance system and certification

Marle's entire industrial production and management are certified under the EN ISO 13485 international medical quality assurance model.

Marle's unique focus on orthopaedics has led our teams to implement and continuously enhance a specific quality management system that puts the stress on traceability and reliability:

• Strict regulatory compliance
• Special processes validation
• Risk analysis (ISO 14971)

Marle exclusively works with an approved and validated supplier list, has implemented a flawless raw material quality control scheme to increase reliability and neutralize variation.

A systematic approach to medical risk management

Marle's highly specialized activity on orthopaedics implants has shaped several proprietary quality-assurance procedures and tools addressing the healthcare market : validation sampling techniques, Geometric Dimensioning and Tolerancing (GD&T), scientific process development and sterilization management, comprehensive process documentation, scientifically assessed risk analysis and statistically optimised manufacturing processes, etc.

Our quality system translates into total traceability, complete document management and thorough testing, and therefore end-user medical risk is perfectly controlled.

Continuous training and significant investment

Marle corporate strategy lays significant stress on employees' empowerment and skills improvement. Each Members of our teams benefits from a continuous training path fitted to their needs. Our training programs address management, quality, technical and basic skills alike.

Our investment strategy matches our quality requirements and provides our teams with latest generation control systems and laboratories:

• Mechanical tests (impact, hardness and micro hardness, tensile, etc.)
• Profile projectors
• 3D (CMM) inspection (7 centres)
• Automatic air gages
• NDT (penetrant testing, X-ray, fibroscopy, endoscopy)
• Metallographic inspection (grain, corrosion, fracture, surface, structures, cleanliness, porosity, contents, Al- pha-Case and contaminated layers, flow lines...)
• Spectrometry

Standard-based validation

Marle's validation approach is based on a strong standard watch in order to fit to best-in-class requirements (ISO and ASTM). Thus, packaging validation is made in accordance to ISO 11607 requirements. Hydroxyapatite coating is validated in accordance to ISO 13779. Final Cleaning validation is based on NF S94-091.