Medical Device Manufacturers
Accumedix, Inc
800 Liberty Dr, Libertyville, IL 60048, United States
- Founded 2001
- ISO 13485, ISO 9001
- Clinical trial to full production scale
About Accumedix, Inc
Accumedix, Inc. was founded in 2001 and operates from Libertyville, Illinois. The privately held company is led by President Paul J. Serio, a medical device industry veteran with over 35 years of experience at Baxter Healthcare and Fenwal Blood Technologies, and Vice President of Regulatory Affairs and Quality Michele H. Kupcso, who brings similar depth from Baxter and Allegiance Healthcare. Serio joined after global IT acquisitions and SAP implementations, while Kupcso previously ran an international regulatory consulting firm. The company provides end-to-end medical device commercialization services, spanning design and development, quality management system implementation, contract manufacturing, assembly and packaging, and distribution. Its Libertyville facility includes clean room and white room manufacturing environments capable of handling clinical trial runs through full production scale. Services include sterile packaging, sterilization coordination (including ethylene oxide requalification and quarterly dose audits), lot-controlled warehousing, and drop-shipping. Accumedix also offers a subscription-based quality management system that covers FDA and European management representation, annual registrations, audits, and supplier quality oversight. Its client engagements cover catheter assembly, electromechanical device assembly, and broader device commercialization programs that require regulatory submissions such as 510(k)s, European technical files, and FDA quality system compliance. The company's stated mission is to develop and commercialize new medical device technologies while generating returns for investors through outstanding customer value.
Manufacturing capabilities
Core processes
Finishing & coating
Inspection & quality
Industries served
- Medical Devices
Company details
- Location
- Libertyville, Illinois
- Founded
- 2001
- Production volume
- Clinical trial to full production scale
- Certifications
- ISO 13485, ISO 9001, ISO MDSAP, FDA 21 CFR Part 820, UL
- Listed under
Frequently asked questions
Where is Accumedix, Inc located?
Accumedix, Inc is located at 800 Liberty Dr, Libertyville, IL 60048, United States.
What does Accumedix, Inc do?
Accumedix, Inc is listed under Medical Device Manufacturers, and its listed capabilities and products include Design for manufacturability, Design control, Project management, 510(k) submission support, Regulatory facility registration and Device master record maintenance.
What industries does Accumedix, Inc serve?
Accumedix, Inc lists Medical Devices among the industries it serves.
What certifications does Accumedix, Inc have?
Certifications on file for Accumedix, Inc: ISO 13485, ISO 9001, ISO MDSAP, FDA 21 CFR Part 820 and UL.
When was Accumedix, Inc founded?
Accumedix, Inc was founded in 2001.
How do I request a quote from Accumedix, Inc?
Use the Request a quote button on this page to send Accumedix, Inc your requirements through FirmsLedger, or call (847) 548-8499 and visit accumedix.com.
What companies are similar to Accumedix, Inc?
Other Medical Device Manufacturers in Illinois listed on FirmsLedger include Illinois Supply Company, Med Tech Sweden and Terrain Biomedical, Inc..