Shenzhen Alu Rapid Prototype Precision Co., Ltd.

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  • Key Considerations of medical device prototyping

Regulatory Compliance: Align with FDA, ISO 13485, or regional standards from the outset to avoid delays.

Precision: Medical devices often require tight tolerances (e.g., ±0.01 mm) for safety and performance.

Sterility and Biocompatibility: Select materials and processes that support medical-grade requirements.

Speed: Balance rapid prototyping with thorough testing to meet development timelines.

Cost Management: Prototype tooling (e.g., soft molds) is cost-effective but may need multiple iterations.