Medical Device Manufacturing Quality System
Hudson Medical Innovations provides unparalleled design and fabrication of innovative products for the medical device industries. The dedication to continuously improving products and processes enables us to exceed client expectations.
Medical device manufacturing quality management systems
Our Medical Device Manufacturing Quality Management System, or QMS, is integral to everything we do. Certified to ISO 9001:2015 and 13485:2016, it converts the otherwise intangible factors of your purchase decision into quantifiable, tangible evidence that the medical products we manufacture fit, form, and function as intended. The QMS has also obtained 21 CFR Part 820 approval.
Quality is our culture
At Hudson Medical Innovations, our team only creates products that they feel confident using themselves or giving to loved ones. This promise results from the QMS, which outlines rigorous benchmarks for material acquisition, fabrication, assembly, inspection, and packaging.
We’ve taken steps to ensure that the best raw materials go into products and that manufacturing and quality assurance processes exceed industry standards. Besides holding general and medical device-specific Quality Management System certifications, our manufacturing facility has multiple spaces that are compliant with the ISO 14644 standard for cleanrooms.
To ensure quality standards are maintained, our facility and personnel are assessed by an auditing organization each year. Additionally, we regularly perform internal and external audits and welcome customer audits.
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contact us request informationWhy Hudson Medical Innovations
Advanced Technology and Personnel
Specialize In Custom Based Projects
Inhouse Equipment Experts
Converting Technology Patents
Commitment to the customer
All Hudson Medical Innovations employees are responsible for their work quality and are expected to search for ways to improve products and services. We believe customer satisfaction is a function of providing products and services that are:
- Correct
- Valuable
- Arrive on time
From supplying trusted products to delivering responsive service, you can trust Hudson Medical Innovations with your contract medical product manufacturing needs. We ensure the validity of all processes and offer consistent design, production, and shipment of safe, effective medical devices.
Give us a call for more information about Hudson Medical Innovations quality management systems.
Other Manufacturing Capabilities
Project Management
When embarking on medical device manufacturing projects, many variables can impact finished product quality and time to market. Sometimes, you’re stretched too thin to handle these duties on top of your core business. With project management…
Traditional Manufacturing
Central to successful medical diagnoses and treatments are medical professionals. Likewise, traditional manufacturing methods are the backbone of healthcare and specifically medical device production.
Robotic Assembly
Stringent regulations and increased market demands put medical device creators under pressure to turnaround large quantities of products with little downtime. Streamline production of sought-after multifaceted items with robotic assembly capabilities…
Hudson Medical Innovations
2251 Willis Miller Drive
Hudson, WI 54016
715.386.3774
