Medical Device Contract Manufacturing Certifications & Standards
Hudson Medical Innovations strives to continually improve the products, processes, and services we offer, enabling us to exceed expectations time and again. Our contract medical device manufacturing facility in Wisconsin regularly undergoes rigorous audits for compliance with regulatory standards.
We hold certifications for the following medical device contract manufacturing standards:
ISO 9001:2015
Our Quality Management System adheres to the general requirements of the International Organization for Standardization or ISO. It confirms that the processes, procedures, and protocols we have in place provide quality products and services that meet applicable statutory and regulatory requirements.
ISO 13485:2016
Demonstrates we can provide medical devices and related services that consistently meet applicable customer expectations and regulatory requirements. Aligned with ISO 9001:2015, it proves the processes outlined in our Quality Management System result in the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
ISO 14644
Confirms that specified areas of our facility can control the concentration of airborne particles. In our cleanrooms, factors such as humidity, temperature, pressures are kept within specified limits.
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Always innovating
At Hudson Medical Innovations, client satisfaction is paramount. We don’t just stop at certifications from leading industry and government regulatory agencies.
Our staff undergoes training for competency necessary to ensure compliance with regulatory authorities, regardless of where a device is marketed. They’re experienced in validation, risk management, 510 (k) and PMA submission support, device history records, and change management.
Contact us to learn more about the medical device manufacturing standards for which we’re certified.
Why Hudson Medical Innovations
Advanced Technology and Personnel
Specialize In Custom Based Projects
Inhouse Equipment Experts
Converting Technology Patents
Complete Solution
Hudson Medical Innovations' Contract Manufacturing Services can provide you with all of the resources needed to integrate laser processing and die cutting into your manufacturing stream. The extensive design, testing and manufacturing capabilities of Hudson Medical Innovations can help you answer today’s challenges – enhancing product design, improving quality, lowering unit cost and shortening lead times.
Materials
View AllMedical material science is a relatively new field of study that has emerged at the intersection of physics, chemistry, and engineering. Substances are continually evaluated for biocompatibility. As a result, the types of materials used in medical device manufacturing are virtually endless.
Industries
View AllOne of the great things about Hudson Medical Innovations’ position as a full-service medical device contract manufacturer is the diverse range of clients and products we work with and fabricate.
Hudson Medical Innovations
2251 Willis Miller Drive
Hudson, WI 54016
715.386.3774
