Medical Device Development

Medical Device Development
Concept Through Production

• Custom product design and development from concept through production, and all phases and details in between.
  
• Well on the development path, but need help with the final obstacles? We will get you to market.

Product Development Services

• Complete Design and Development Capabilities.
  
• IEC 60601-1 3rd Ed. compliant design and Testing Agent
• EN 55011 EMC compliant design
• Verification and Validation Testing
• Design Control Documentation
• Risk Management per ISO 14971
• Complete, transfer-ready Device History Record and Device Master Record
• CE Mark
• Graphical User Interface Design
• Embedded Software Development and Verification Testing

Quality Assurance Management Services

We will guide you through implementation of an ISO 13485, ISO 9001, FDA 21 CFR 820, CMDCAS and EU MDD-compliant Quality Management System, and transition quality system management to you as your company grows.

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Production Transfer

• Robust Supply Chain Development
• Production documentation  including Assembly, Test, and Packaging Instructions
• Production and QC  personnel training
• Contract Manufacturer management

Prototype Fabrication

• Custom prototype fabrication capabilities to reduce design iteration time.
• Fully-documented low-volume Clinical Trial Devices
• Manufacturing Fixture Design and Fabrication

Product Development Efficiency

Converging Concepts can help you keep your overhead down during the product development phase. Bring in only the resources you need, when you need them.
Our experienced resources include:

• Program Management
• Mechanical Engineering
• Electrical Engineering
• Software Engineering
• Quality Assurance Management
• Regulatory Affairs Management
• 3D Visualization and Animation Design