Micron's ISO 13485 certified, FDA registered cGMP orthopedic implant manufacturing solutions include precision machining, finishing, porous coatings, passivation, and sterilization.
Our experienced team enables turnkey production of orthopedic implants and other advanced devices from Micron’s 120,000 square foot manufacturing facility located outside Boston, Massachusetts. Micron’s ISO 13485 certified manufacturing services provide solutions for orthopedic devices ranging from permanent biocompatible device housings to osseointegrated implants, as well as precision-machined removable support structures.
Micron utilizes the most technologically advanced machining and processing capabilities to quickly and accurately produce high-quality orthopedic implants and devices. Different materials and techniques yield varying performance characteristics, and Micron’s extensive experience with a diverse range of materials and products ensures optimal process development based on material characteristics and application requirements. From pre-product launch to high-volume legacy products, our team of engineers works with you to evaluate manufacturability and develop processes optimized to match the phase of product readiness and scale, resulting in cost reduction, yield improvement, and timeline compression.
Orthopedic implants interface with the human body and require stringent processes to ensure quality and compliance. As a leading supplier to medical device companies and orthopedic implant OEMs, Micron integrates quality control throughout its entire production process, achieving the highest levels of quality and consistency in the manufacturing of orthopedic implants. Whether working with an innovation start-up or an established medical OEM, quality management systems are co-developed with customers, with Micron’s engineering team supporting our manufacturing capabilities with process development and validation procedures under the guidelines of ISO 13485. From materials verification to operational validation, and final inspection, each stage of the process is rigorously documented and quality-checked in accordance with customer specifications and FDA requirements.
Copyright © 2023 Micron Products INC. All rights reserved.