ACCUMEDIX, INC.

Accumedix is a contract medical device design, development, manufacturing, and regulatory consulting firm headquartered in Libertyville, Illinois. Founded in 2001, the company provides comprehensive services for bringing medical device innovations from concept to market, serving clients from individual inventors to Fortune 1000 enterprises. Core competencies include design and development integration with manufacturing and regulatory considerations, quality management system implementation, cleanroom and white room contract manufacturing, assembly and packaging at any volume, and marketing and distribution support. Accumedix maintains FDA registration and holds ISO 13485, ISO MDSAP, UL, and Medical Device Directive certifications. The facility operates under FDA Quality System Regulation 21 CFR Part 820 and is recognized by European Notified Bodies. The company specializes in regulatory and quality consulting, helping clients navigate FDA submissions and quality system compliance. Accumedix distinguishes itself through process-focused partnerships that allow clients to concentrate on product innovation while the company manages quality, regulatory, and manufacturing processes. Services extend to small-batch and custom volumes, addressing clients who cannot meet minimum volumes required by traditional contract manufacturers.