McFarlane Medical maintains a meticulous quality system that is ISO 13485 compliant (Certified by DEKRA) and FDA 21CFR 820 compliant.​

We place great emphasis on providing products and services that are defect-free and meet, or exceed, both regulatory and customer requirements.

McFarlane Medical employs a stringent quality management system to ensure consistent quality and lean manufacturing principles and Kanban inventory techniques to eliminate waste and control costs. We operate a variety of production environments which are certified to ISO Class 7 and Class 8. We can quickly expand our specialized manufacturing capacity to meet special demands.​