Fix Surgical
Provider of contract design and private-label outsourcing services for medical device OEMs, with a focus on orthopedic device and instrument development. Operates a cross-functional team of engineers, project managers, regulatory personnel and surgical advisors to deliver concept development, engineering design, prototyping, regulatory support, and project management aimed at accelerating time-to-market and reducing development cost.
Industries
Nr. of Employees
small (1-50)
Services
Cross-functional ideation and development of device concepts, full design packages or focused component improvements.
Translation of early concepts into engineering specifications, drawings and requirements using DfX practices to prepare for manufacturing and test.
Identification of regulatory requirements, development of design controls and documentation to support FDA 510(k) and CE marking readiness and alignment with ISO 13485.
Provision of rapid prototypes for evaluation of form, fit and function to de-risk design decisions and accelerate development iterations.
Coordination of cross-functional teams with disciplined controls to deliver projects on schedule and within budget.
Cross-functional ideation and development of device concepts, full design packages or focused component improvements.
Translation of early concepts into engineering specifications, drawings and requirements using DfX practices to prepare for manufacturing and test.
Identification of regulatory requirements, development of design controls and documentation to support FDA 510(k) and CE marking readiness and alignment with ISO 13485.
Provision of rapid prototypes for evaluation of form, fit and function to de-risk design decisions and accelerate development iterations.
Coordination of cross-functional teams with disciplined controls to deliver projects on schedule and within budget.
Expertise Areas
- Medical device design and development
- Design for Manufacturability and DfX
- Regulatory compliance and submission preparation (510k, CE, ISO 13485)
- Rapid prototyping and prototype validation
Key Technologies
- Design for Manufacturability (DFM)
- Design for Testability (DfT) / Design for Assembly (DfA) / Design for Cost (DfC)
- Rapid prototyping for form-fit-function
- Design controls and Design History File (DHF) processes