FDA Registered  |  ISO 13485:2016  |  ISO 11137-1:2006/Amd 2:2018  |  ISO 11135:2014/Amd 1:2018

Medical Product Design & Development

Domico Med-Device collaborates with companies to design and develop innovative healthcare products for diagnostic imaging, image-guided therapy, and surgical applications.

 

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WHO WE ARE

Trusted Manufacturer of Medical Products.

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.

 

 

OUR VALUES

The Foundation of Everything We Do.

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Be Humble, Be Curious

Seek understanding. Ask, don’t
assume. Be open to receiving
questions and sharing
knowledge.

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We Work as a Team & Build Relationships

Be respectful Engage co-workers
customers, and suppliers for
solutions. Don’t go it alone, all
of us will be smarter than any
one of us.

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Simple is Best

Don’t make a mountain out of a
mole hill. Practical promotes
compliance. When a challenge
occurs focus on what we can do.

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Quality Work, First Time, Every Time

Always assure quality at the
source. Timely corrections, fix it
forever. Better to be a day late and
right than on-time and wrong.

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Work Safely

Safety is everyone’s responsibility. Be
confident in your safety and the safety of our
co-workers. Uncertain about safety, STOP!
Seek assistance, seek correction.
Ready to Innovate? Let’s Create the Future of Medical Devices Together!
OUR CAPABILITIES

Design & Development

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:

Concept Development
Collaborating with you to understand your ideas and refine them into actionable design plans.


Prototyping
Creating prototypes that allow for hands-on testing and validation of concepts.


User-Centered Design
Focusing on the end-user experience to enhance usability and satisfaction. 



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We're Invested In Your Success.

With a long history of successful partnerships with OEMs and inventors, Domico Med-Device can help your organization with medical product design, development, and manufacturing. Simply fill out the form and a member of the team will reach out to discuss your needs.

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Quality Manufacturing Every Time

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.

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Production Capabilities

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.

Learn More  →

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Reliable Delivery, Every Time

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.

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OUR CAPABILITIES

Engineering Excellence

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.

 

Let's discuss how Domico Med-Device can be your trusted partner in Medical Product Design & Development.
QUALITY ASSURANCE

Quality is at the heart of everything we do.

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.

 

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FDA-Registered and ISO 13485:2016 Certified

As an FDA-registered and ISO-certified facility, Domico Med-Device ensures that all products meet the highest standards for quality and regulatory compliance.

99% On-time Performance

We value your time, and the time of your customers. That’s why we promise to create a schedule that aligns your requirements with our capabilities.

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State-of-the-Art Facilities

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.

 


 

See our full list of capabilities by downloading our capabilities guide.

Client Testimonials

In my time working with Domico Med-Device, they have continuously demonstrated this understanding. Their design outputs meet the actual needs of doctors and nurses, with ongoing collaboration with clinicians to receive their essential feedback. I have also been impressed with their innovative approach to new product ideas. Not only did they listen to customer feedback to improve the product, they created additional product designs as well.
Onno Wink
PhD, Clinical Scientist

 

Ready to bring your medical device idea to life?

Contact us today to discuss how Domico Med-Device can be your trusted partner in Medical Product Design & Development.

 

Call us: 810-750-5300

Email us: orders@domicomed.com