Shenzhen Alu Rapid Prototype Precision Co., Ltd. Industry News Home News 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.