Prototyping

What is Prototyping for Medical Devices?

As DM actor, you could be interested in having a partner who provides comprehensive prototyping services. These services typically include the design technical review, production, and packaging of different medical devices.

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

We invest in expertise and advanced technology to ensure that your medical devices meet regulatory standards and quality requirements. This way, the product can be marketed quickly and safely.

What Is Our Production Scope ?

Applus+ Laboratories ensures high-precision thorough finishing, anodising, laser marking, assembling, and comprehensive cleaning and packaging solutions, all within a meticulously controlled and compliant environment (ISO 9001 and ISO 13485 certification).

Finishing and Assembling

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.

Titanium Anodizing

We have a wet surface treatment line for anodizing titanium parts. This process exploits a fantastic property of titanium: it coats itself with a unique coloured oxide layer depending on the voltage applied during treatment. This property is particularly useful within a range of products that can be easily distinguished in the operating room, but also for aesthetic and marketing criteria.

Cleaning and Packaging

Applus+ Laboratories' dedicated clean room facilities (ISO 7) support our comprehensive cleaning and packaging (non-sterile and sterile) services. We manage laser marking, cleaning, and packaging with the utmost care, ensuring that all products are prepared and packaged in 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 Our Prototyping Services?

Starting your qualification with 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: We aim to reduce operational costs related to staffing, training, and equipment maintenance.
• Access to Expertise and Technology: We offer regulatory compliance expertise, alongside access to the latest equipment and technological advancements.
• Flexibility and Scalability: We 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, we ensure products meet necessary standards and maintain consistent quality through robust control systems.
• Focus on Core Competencies: Outsourcing allows companies to concentrate on research, development, and other core activities, enhancing operational efficiency and innovation.

Why Choose Applus+ Laboratories As Your Partner?

If you choose Applus+ Laboratories from the very start of your project, you’ll be partnering with a leader in medical device testing solutions.

We provide not only high-quality assembling services, but reduced time and qualification costs thanks to our large and comprehensive range of testing capabilities and we are also fully committed to client service, which makes us the ideal partner.

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