Fix Surgical

Fix Surgical is a medical device design and development outsourcing firm specializing in orthopedic surgical solutions. The company employs a private-label and contract manufacturing model to assist original equipment manufacturers (OEMs) in reducing design and development costs while accelerating time to market. The firm's core competencies include concept development, design for manufacturability (DFM), engineering design specifications, regulatory compliance, rapid prototyping, and project management. Fix Surgical maintains an in-house team of engineers, project managers, and regulatory specialists, supplemented by an advisory board of surgeons and a network of industry-leading engineers. The company supports the full product lifecycle from feasibility analysis and design control through prototyping, risk analysis, validation, and launch. Services encompass design for excellence (DFX) methodologies incorporating design for cost (DfC), design for assembly (DfA), and design for testability (DfT). Fix Surgical has demonstrated expertise in obtaining FDA 510(k) clearance and CE Mark certification while maintaining ISO 13485 quality standards. The company focuses on orthopedic markets and custom surgical instrument trays, positioning itself as a partner for OEMs seeking to innovate efficiently without maintaining full internal R&D infrastructure.