A complete design package you can transfer
Every program leaves behind a complete, transferable design package — models, drawings, analysis and documentation that your quality system and your suppliers can work from directly.
We work in close collaboration with your team and your suppliers to ensure each step in the process meets all quality and regulatory standards, including FDA cGMP and ISO 13485.
Analysis before you cut steel
Analysis is used where it changes a decision. Component FEA and failure modes and effects analysis identify weak points while they are still inexpensive to fix, and photorealistic renderings let stakeholders review a design long before parts exist.
- SolidWorks and Pro/Engineer CAD
- Photorealistic product renderings
- Engineering drawings and documentation
- Component FEA and failure modes and effects analysis
What this service includes
CAD modelling in SolidWorks and Pro/Engineer, photorealistic product renderings, engineering drawings and design documentation, component finite element analysis, failure modes and effects analysis, and documentation prepared to FDA cGMP and ISO 13485 requirements.
Yes. Design and documentation are prepared for FDA cGMP and ISO 13485 compliance, so the design history transfers cleanly to your quality system.
Yes. Deliverables are handed over as native or neutral CAD together with drawings and supporting documentation, so you are not locked to us.
