PHASE 3

We guide you through our Design for Manufacturing (DFM) and regulatory compliance process so that your device meets industry standards and is ready for market approval.

Deliverables: 

• Design tolerance stack-ups to ensure all parts of the design fit together and can be assembled seamlessly.
• Regulatory Strategy & Documentation – A structured approach to meet compliance requirements, including necessary filings and documentation.
• Risk Management & Quality Assurance Plan – Identification and mitigation of potential risks, ensuring adherence to industry quality standards.
• DFM Analysis Report – Evaluation of design for manufacturability to optimize production efficiency and cost-effectiveness.
• Detailed technical blueprints and clearly defined specifications to guide production.
• Access to native SolidWorks design files so you can seamlessly integrate them into your quality control system.
• Weekly 60-minute strategy sessions to inform and refine the DFM process.