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OEM Manufacturing

Custom orthopedic device manufacturing tailored to your specifications

World-Class OEM Manufacturing Services

At Orthopromed Inc., we offer comprehensive OEM (Original Equipment Manufacturer) services for orthopedic medical devices. Whether you need custom product development, private labeling, or contract manufacturing, our state-of-the-art facilities and experienced team deliver excellence at every stage.

Custom Design & Development

Work with our R&D team to design and develop custom orthopedic devices that meet your exact specifications and clinical requirements.

Precision Manufacturing

Advanced CNC machining, injection molding, and assembly processes ensure consistent quality and precise tolerances.

Quality Assurance

ISO 13485 certified facility with comprehensive quality management systems and rigorous testing protocols.

Regulatory Support

Expert guidance through FDA 510(k), CE marking, and other regulatory approval processes worldwide.

Scalable Production

Flexible manufacturing capacity from prototyping to full-scale production runs, adapting to your market demands.

Private Labeling

Complete branding and packaging solutions to market products under your own brand name.

Our OEM Manufacturing Process

From concept to delivery - a seamless partnership

1

Consultation & Requirements

Initial consultation to understand your product specifications, target market, regulatory requirements, and business objectives.

  • Product specifications review
  • Technical feasibility assessment
  • Regulatory pathway planning
  • Cost estimation and timeline
2

Design & Development

Our engineering team works with you to develop detailed designs, create prototypes, and conduct performance testing.

  • CAD modeling and engineering
  • Prototype development
  • Material selection and testing
  • Design verification and validation
3

Regulatory & Quality

Comprehensive documentation and testing to ensure compliance with FDA, ISO, and international standards.

  • Quality management system setup
  • Design history file preparation
  • Biocompatibility testing
  • Regulatory submission support
4

Production Setup

Manufacturing process development, tooling creation, and production line validation for efficient manufacturing.

  • Process development and optimization
  • Tooling and fixture design
  • Production validation
  • Standard operating procedures
5

Manufacturing & Delivery

Full-scale production with continuous quality control, packaging according to your specifications, and timely delivery.

  • Scalable production runs
  • In-process quality inspection
  • Custom packaging and labeling
  • Global logistics and shipping

Certifications & Compliance

Meeting the highest industry standards

ISO 13485

Medical Device Quality Management System

FDA

FDA Registered Manufacturing Facility

CE

European Medical Device Directive Compliance

GMP

Good Manufacturing Practice Certified

Ready to Bring Your Product to Life?

Let's discuss your OEM manufacturing needs and develop a custom solution

Chat with us