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

Medical Device Manufacturing

At Domico Med-Device, we are committed to delivering high-quality medical device manufacturing solutions that meet the needs of healthcare companies.

 

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WHO WE ARE

We are a dedicated team of professionals committed to excellence in medical device manufacturing.

Founded on the principles of integrity, collaboration, and continuous improvement, our company has built a reputation as a trusted partner in the medical device industry. We pride ourselves on our ability to understand the unique challenges faced by our clients, providing tailored manufacturing solutions that meet their specific needs.

 

 


Why choose us?

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Expertise and Experience

With decades of experience in medical device manufacturing, our team of experts brings a wealth of knowledge and skills to every project. We understand the complexities of the industry, allowing us to provide innovative solutions that drive success.

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Comprehensive Services

From initial design to final production, our comprehensive manufacturing services ensure that every aspect of your project is managed with precision. This integrated approach reduces handoffs and enhances communication, leading to successful outcomes.

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Client-Centric Approach

We believe in building strong partnerships with our clients. Our client-centric approach means we prioritize your needs and objectives, working collaboratively to deliver solutions that exceed your expectations.

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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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.

OUR EXPERTISE

Advanced Manufacturing Technologies

Our state-of-the-art facilities are equipped with advanced machinery and innovative processes, enabling us to create complex components with precision and efficiency. This commitment to technological advancement allows us to deliver reliable and effective medical solutions tailored to your needs.

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Commitment to Quality and Compliance

Navigating the regulatory landscape is crucial for medical device manufacturers. At Domico Med-Device, we prioritize compliance to ensure that your products meet all necessary regulations and standards, facilitating a smooth path to market.

 

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ISO 13485 Certification

Our adherence to the ISO 13485 standard reflects our commitment to maintaining rigorous quality management systems throughout our operations. 

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Comprehensive Quality Control

We implement detailed quality control protocols at each stage of production, from raw material inspection to final product testing, to guarantee the highest quality.

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Testing and Validation

Our rigorous testing processes include functional, performance, and safety assessments, ensuring that every device meets or exceeds industry standards before reaching the market.

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OUR EXPERTISE

Customized Solutions

Understanding that each client has unique requirements, we offer customized manufacturing solutions tailored to your specific needs. Whether you need small-scale prototypes or large-scale production runs, our flexible manufacturing processes can adapt to your project’s demands.

Tailored Manufacturing Processes
We customize our manufacturing techniques to align with your product requirements, ensuring optimal performance and efficiency.

Scalability
Whether you need small-batch prototypes or large-scale production, our manufacturing capabilities can scale to meet your changing demands without compromising quality.

Material Selection
We assist in selecting the right materials for your device, considering factors such as biocompatibility, durability, and cost-effectiveness to ensure the final product meets industry standards.

 


OUR EXPERTISE

Continuous Improvement

At Domico Med-Device, we believe that the pursuit of excellence is an ongoing journey. Our commitment to continuous improvement is integral to our manufacturing processes, ensuring that we consistently deliver high-quality medical devices that meet the evolving needs of the healthcare industry.

Regular Process Evaluations
We conduct routine evaluations of our manufacturing processes to identify areas for improvement. By analyzing performance metrics and feedback, we implement changes that enhance operational efficiency and product quality.

Feedback Loops
We actively seek input from clients and stakeholders to understand their experiences and identify areas for enhancement. This feedback is crucial in refining our processes and services to better meet client expectations.

Performance Metrics
We utilize key performance indicators (KPIs) to measure the effectiveness of our processes and identify opportunities for improvement. By analyzing these metrics, we can make data-driven decisions that enhance efficiency and product quality.

 

 

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Domico Med-Device can help your organization with medical product design, development, and manufacturing.
OUR PROCESS

From prototyping and design validation to full-scale production and post-production support

 

Proven Process

 

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

 

Get in touch with us!

Whether you have a specific project in mind or need guidance on how to bring your medical device idea to life, our expert team is ready to assist you.

Let's connect withto discuss your needs and explore how Domico Med-Device can be your trusted partner in achieving your manufacturing goals.

 

Call us: 810-750-5300

Email us: orders@domicomed.com