We Commercialize Medical Device Technologies
Full Medical Device Services with Regulatory and 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 Grayslake, IL.
Our Accumedix facility is FDA registered and has obtained ISO 13485 and ISO 13485CMDR certifications for European Notified Body, Canada, DQS, Medical Device Directive and FDA Quality System Reg. 21 CFR Part 820. ASQ Certified Quality Engineer and Quality Auditor maintained on staff.
Accumedix customers range from individual inventors to Fortune 100 companies. We also provide consulting expertise to our customers on product design, development and manufacturing. Quality and Regulatory consulting also provided by Accumedix and through our partner Vantage Consulting.
Why is Accumedix different?
No matter the stage of development, we can help add value to your medical device.
Complete Regulatory and Quality Support
We help you focus on innovation instead of complex quality systems and regulatory processes. Our subscription based Quality System is unique to the industry.
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.
We have full-service solutions so that 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.
We provide clean room and non-clean room manufacturing, assembly, kitting and packaging under the control of our world class quality system.
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 from one to millions.
Quality Management System
Subscribe to our quality system for a fraction of the cost of building your own and launch your product in weeks, not months. Let us be your representative with the FDA and other auditors.
Marketing + Distribution
We’ll work closely with you to develop your vision for your product, and make sure you can focus on the product rather than the process.
For a quote, more information, or any question at all – send us a note.