Contract Manufacturing Organisation (CMO)

What is a Contract Manufacturing Organisation (CMO)?

A Contract Manufacturing Organisation (CMO) is a company that provides comprehensive manufacturing services to medical device firms. These services typically include the design, development, production, and packaging of different medical devices.

CMOs offer specialised expertise and advanced technology to ensure that medical devices meet regulatory standards and quality requirements. This way, the product can be marketed quickly and safely.

At Applus+ Laboratories we specialise in high-precision machining of technical parts and plastic injection for prototyping and mass production, offering comprehensive solutions for orthopedics, spine, dental, and maxillofacial applications.

What Services do we offer as a Contract Manufacturing Organisation?

As a CMO, Applus+ Laboratories ensures high-precision manufacturing, thorough finishing and assembling, and comprehensive cleaning and packaging solutions, all within a meticulously controlled and compliant environment.

Manufacturing

At Applus+ Laboratories, we are equipped with state-of-the-art Swiss turning, milling, and multi-axis CNC milling machines, enabling us to produce up to 100,000 high-precision products annually. Our manufacturing capabilities cover a wide range of materials, including PEEK, POM, titanium, cobalt, and more, all within a meticulously controlled ISO 13485 environment, ensuring the highest standards of quality and safety.

Finishing and Assembling

Our commitment to excellence extends beyond manufacturing. In our finishing and assembly departments, we perform thorough dimensional control, allowing us to assemble complex implants in-house with precision and reliability. Our finishing processes include tribofinishing, sandblasting, and sophisticated laser marking and engraving, ensuring each component meets stringent specifications and industry standards.

Cleaning and Packaging

Applus+ Laboratories' dedicated clean room facilities (ISO 7) support our comprehensive cleaning and packaging services. We manage laser marking, cleaning, and packaging with the utmost care, ensuring that all products are prepared and packaged in a sterile, controlled environment, ready for distribution to the medical sector. This integrated approach allows us to provide seamless, end-to-end solutions for our clients, enhancing efficiency and product integrity at every stage of production.

What Are the Benefits of Contract Manufacturing Organisation?

Hiring a CMO such as Applus+ Laboratories will provide your company many different benefits, from cost efficiency to assured quality and compliance, allowing you to focus on the development of your medical devices. These benefits include:

• Cost Efficiency: CMOs eliminate the need for substantial capital investment in manufacturing facilities and reduce operational costs related to staffing, training, and equipment maintenance.
• Access to Expertise and Technology: CMOs offer specialised manufacturing knowledge and regulatory compliance expertise, alongside access to the latest equipment and technological advancements.
• Flexibility and Scalability: CMOs provide the ability to adjust production volumes based on market demand, ensuring efficient scaling and faster time-to-market for new products.
• Quality Assurance and Compliance: With deep regulatory expertise, CMOs ensure products meet necessary standards and maintain consistent quality through robust control systems.
• Focus on Core Competencies: Outsourcing to a CMO allows companies to concentrate on research, development, and other core activities, enhancing operational efficiency and innovation.

Why Choose Applus+ Laboratories as your Contract Manufacturing Organisation?

If you choose Applus+ Laboratories as your Contract Manufacturing Organisation, you’ll be partnering with a leader in medical device testing solutions.

We provide high-quality manufacturing & assembling services, amongst other ones, to ensure the accuracy and reliability of your medical devices. Not only we offer you a comprehensive range of testing capabilities, but we are also fully committed to client service, which makes us the ideal partner as your CMO.

Applus+ Laboratories’ goal is to be a one-stop shop for medical device testing, offering a full range of services that can speed up your time to market. We offer:

• Development testing and advice on improvements
• Full lifecycle testing
• Product and process qualification with batch release tests

Operating in several countries, we offer our testing services worldwide, guaranteeing you access to the highest quality medical device testing and CMO services wherever you are.