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Medical device design and development requires skilled experience to provide product designs that:
- Meet critical functional requirements.
- Are user friendly under precision circumstances.
- Effectively complete verification and validation protocols.
- Are producible for the market.
PEI’s medical device product development team provides our clients the required skill sets for an effective device development solution. PEI has medical device design expertise in the following fields:
- Endoscopic
- Arthroscopic
- Cardiac
- Colorectal
- Precision detail part design
A successful development program requires:
- Strong adherence to client quality systems
- Project management for all of the phases of development
- Scope control – Adherence to medical industry protocols
- Schedule control
- Budget control
Effective device solution requires:
- Concept development & refinement
- Solid modeling for complex, high end, geometry development
- Photo-realistic rendering
- Look and feel physical models and renderings
- Full product functional development
- Refinement through Clinical trials
- Device testing and measuring
- Molded parts / Mechanized parts
- FMEA – Failure Modes and Effects Analysis
- DFA – Design for Assembly
- DFM - Design for Manufacturability
- Analysis:
- Linear and non-linear strength of material (FEA)
- CFD – Computational Fluid Dynamics
- Mechanism Static and Dynamic analysis
- Manufacturing
- Prototype build
- Short run production
- Fixture design & build.
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