Quality control in the manufacture of medical devices includes rigorous dimensional, visual, and mechanical inspections. Each part is tracked at every stage through a comprehensive traceability system, from raw materials to the finished product. This process ensures safety, compliance, and reliability, in accordance with ISO 13485 standards.
Services and Quality Control
Phen’x Technologies does more than just machine parts for its customers: it acts asa technical and strategic partnerto ensure the safety, performance, and compliance of medical devices.
Prototyping and mass production
- Manufacturing of implants, screws, plates, pins, intervertebral cages, surgical instruments, and all other medical devices.
- Manufacturing ofcomplex, high-precision parts, from prototyping to mass production.
- Specialized surface treatments such as medical-grade polishing, passivation, anodizing, or biocompatible coatings.
- Laser marking to ensure the traceability of devices.
- Assembly of subassemblies.
- Cleaning and packaging to prepare devices for immediate use in a hospital setting.
Quality Control and Traceability
- Dimensional measurements (2D and 3D) and surface roughness measurements, optical inspections.
- Complete documentationin compliance with ISO 13485 requirements (traceability, compliance reports).
- Good Manufacturing Practices in accordance with ANVISA and FDA requirements
Consulting and design support
- Regulatory compliancesupport (CE marking, DDM, technical documentation).
- Expertise in new product development .
- Product lifecycle management, reverse engineering, and continuous improvement (products and processes).