FDA Registered | ISO 13485:2016 | ISO 11137-1:2006/Amd 2:2018 | ISO 11135:2014/Amd 1:2018
At Domico Med-Device, we provide a broad range of capabilities to manufacture an extensive portfolio of medical products. Whether the need is one of our standard product solutions or optimizing a customer’s design for manufacturability, our extensive portfolio of resources and experience are available to address your needs.
So no matter your requirements — an existing product or something new we can help you address your specific needs.
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Our expert team offers a full suite of design services, ensuring that every aspect of your product is meticulously crafted to meet user needs. Our design capabilities include:
As an FDA-registered and ISO 13485:2016 certified medical device manufacturer, we manufacture products that meet all specifications and relevant regulatory requirements. Thanks to rigorous quality management throughout our manufacturing process, we build medical products that work as intended time and time again.
Our range of manufacturing capabilities ensure we can cater to a wide range of medical product applications. Coupled with our engineering services, we can work from concept to prototype through to production. We can flex and scale our capabilities which include carbon fiber, compression molding, product assembly, foam fabrication, sewing, sealing, coating, vacuum forming, and more.
As a trusted medical product manufacturing partner, we pride ourselves on our great track record of effective communication and delivering quality products on time. Should we encounter an unexpected delay that compromises a commitment, we won’t leave you in the dark. We’ll keep you informed and work to avoid gaps in supply.
With a robust engineering team, we apply the latest technologies and best practices to ensure that your product is not only innovative but also reliable and safe. Our engineering services encompass:
Mechanical and Electrical Engineering
Comprehensive support for all technical aspects of your device.
Materials Selection
Expert advice on selecting the right materials for durability and compliance.
Regulatory Compliance
Navigating the complex regulatory landscape to ensure your product meets all necessary standards.
Our commitment to quality is reflected in our certifications and compliance with industry regulations, giving you peace of mind that your devices are safe and effective.
Stringent Quality Control Protocols
From initial concept development to final production, our teams conduct thorough inspections and testing to identify and address any issues before they affect the end product.
Continuous Improvement
We regularly review our processes and implement enhancements based on industry best practices, client feedback, and emerging technologies.
Risk Management
By identifying potential risks early in the development process, we implement measures to mitigate them, ensuring that our products are not only safe but also effective in real-world applications.
As an FDA-registered and ISO-certified facility, Domico Med-Device ensures that all products meet the highest standards for quality and regulatory compliance.
At Domico Med-Device, our commitment to excellence is reflected in our state-of-the-art manufacturing facilities, designed to support the highest standards of medical device production.
Environmentally Controlled Production Environment
To safeguard product integrity and maintain compliance with regulatory standards, these spaces are meticulously maintained to prevent contamination.
Quality Control Systems
This ensures that every product is rigorously tested and meets our high standards of quality and performance before it reaches the market.
Scalability
Our facilities are designed for scalability, enabling us to efficiently scale production volumes to meet your demands, whether for small-scale prototypes or large-scale manufacturing runs.
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