Case Study: Hu-Friedy, global leader in dental instruments, achieves FDA and ISO compliance and cuts document cycle time with MasterControl

MasterControl™ Supports Hu-Friedy, Global Leader in Dental Instruments, in FDA and ISO Compliance Efforts

Hu-Friedy, a Chicago-based global leader in handcrafted stainless-steel dental instruments, needed to maintain strict FDA (21 CFR Part 820) and ISO 13485 compliance across complex, multi-step manufacturing and documentation processes. With more than 35 operations involved in producing a single instrument and over 400 employees, the company’s paper-based document control—manual routing, tracking, and change notices—was slow, error-prone, and difficult to keep current.

Hu-Friedy implemented MasterControl beginning in 2000, trained staff, validated the system to meet 21 CFR Part 11, and integrated it across departments to control drawings, specifications, external documents and more. The electronic system tripled user licenses, cut document-change cycle time from about four weeks to one week, improved revision control and process visibility, reduced obsolete documents on the shop floor, and strengthened FDA/ISO compliance while delivering measurable time and cost efficiencies.

Hu-Friedy

Keith Dunn

Director of Regulatory Affairs