CDMO - Rising EO

CDMO

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Introduction to the Program

CDMO（Contract Development and Manufacturing Organization）

Our company offers comprehensive support from process R&D to production services through CDMO. This includes product R&D, manufacturing, quality control, compliance, and other value-added services. We have assembled a professional R&D team with exceptional optical and mechanical design capabilities, enabling customized development of innovative products tailored to complex medical needs.

CMO（Contract Manufacture Organization）

It primarily refers to accepting commissions from medical device companies to provide services related to product manufacturing. These services include but are not limited to process development, large-scale production management, supply chain management, as well as the production and packaging of final products.

MAH（Marketing Authorization Holder)

An enterprise with a medical device registration certificate (the principal) can entrust a third-party enterprise (our company) for production. In entrusted production, a qualified entrusted party can directly produce according to the terms and conditions stipulated in the entrusted production contract; alternatively, the entrusted party can apply for a production license based on the principal's authorization letter to carry out entrusted production.

Entrusted Licensing

An enterprise (principal) can entrust a third party (our company) to handle both medical device registration and production licenses through a commission agreement.

Company Advantages

Professional Team

A team that brings together talents from various fields such as optics, mechanics, structural engineering, and possesses outstanding interdisciplinary research and development capabilities.
Innovative Design

Leveraging cutting-edge optical capabilities, we can customize innovative products tailored to intricate medical requirements.
Comprehensive Services

Providing a one-stop solution from concept to mass production, covering design, production, quality control, compliance, and post-production support.
Rigorous Quality Control

We have established a quality management system compliant with international standards, ensuring high-quality product output.

Service Content

Product Research and Design

Needs Analysis: Deeply understand customer requirements, combine market trends and regulatory requirements, and provide customized product solutions.

Design Development: Based on customer needs, conduct conceptual design, optical design, structural design, etc., to ensure that the product meets both customer and market demands.

Design Simulation: Utilize advanced design software and simulation technology to conduct optical simulations and structural optimizations, reducing design iteration cycles.

Sample Production: Create prototypes based on designs for preliminary functional verification and performance testing, laying the foundation for subsequent manufacturing.
Production Manufacturing

Production Process R&D: Develop suitable production processes tailored to product characteristics to ensure stability and consistency in product quality.

Customized Production: Flexibly accommodate small-batch, multi-variety production needs, meeting personalized customization requirements.

Scalable Production: Equipped with a 700-square-meter (including under construction) GMP-compliant clean workshop and senior production and quality control personnel, we possess large-scale production capabilities to meet market demands.

Supply Chain Management: Manage raw material procurement, inventory control, and other aspects to ensure smooth production.
Quality Control and Compliance

Quality Management System: Certified as a medical device manufacturer according to ISO13485 standards, we have established a strict quality management system based on ISO9001 to supervise the entire production and inspection process, ensuring product quality complies with relevant standards and regulatory requirements.

Continuous Improvement: Through regular audits and internal reviews, we continuously optimize the quality management system, improving product quality and compliance levels.

Registration and Certification: Assist customers with product registration and certification processes, including domestic and international market registration and certification procedures.
Registration and Declaration

Registration Document Preparation: According to regulatory requirements, prepare product registration documents, including technical documentation, clinical trial reports, etc.

Registration Submission: Assist customers in submitting registration applications to relevant regulatory agencies and track the review progress.
Other Value-added Services

Risk Management: Assess and manage potential risks in product research and development and production processes, reducing potential defects and minimizing corporate losses.

Post-market Support: Provide technical support and after-sales service after product launch to ensure that customer products remain competitive in the market.