We Commercialize Medical Device Technologies
Full Medical Device Services with Regulatory & Quality Support To Get Your Idea To Market
Accumedix provides complete services to develop your ideas into innovative medical devices. We have been in operation since 2001 and are located in Libertyville, IL. Our Accumedix facility is FDA registered and has obtained ISO MDSAP and ISO 13485 and certifications for European Notified, UL, Medical Device Directive and FDA Quality System Reg. 21 CFR Part 820.
Accumedix customers range from individual inventors to Fortune 100 companies. We also provide consulting expertise to our customers on product design, development and manufacturing. Accumedix also provides Quality and Regulatory consulting and documentation services.
Why is Accumedix different?
No matter the stage of development, we can help add value to your medical device. Here’s how.
Regulatory & Quality Support
We help you focus on innovation instead of complex quality & regulatory processes. We provide unique Regulatory and Quality System consulting & support.
Our Breadth of Experience
We draw on years of experience and top talent from within Accumedix and our trusted partners to make sure your device is commercialized successfully.
Our Process Focus
We’ll work closely with you to develop your vision for your product, and make sure you can focus on the product rather than processes and systems.
Our Solutions
We have fully compliant solutions so you don’t have to navigate medical device quality and regulatory compliance requirements.
Design + Development
We help you design and develop your medical device with the end-customer, manufacturing, quality, and regulatory submission integrated successfully. Learn More About Development…
Quality Management System
Use procedures and forms from our quality system for a fraction of the cost of building your own. Launch your product in weeks, not months. We’ll help you work with the FDA & other auditors. Learn About Quality Systems…
Contract Manufacturing
We provide clean room and white room manufacturing, assembly, kitting and packaging under the control of our world class quality system. Learn More About Manufacturing…
Marketing + Distribution
We’ll work closely with you to develop your vision for your product, including a distribution system. We’ll make sure you can focus on the product rather than the process. Learn More About Marketing…
Assembly + Packaging
Many contract assembly and packaging vendors require large volumes to make it worth their while. We assemble and package any quantity you need. Learn More About Assembly…
Contact Us
For a quote, more information, or any question at all, including Careers – get in touch!