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CONFIDENTIALITY NOTE
This project illustrates the complete product development process, including system architecture, design evolution, and prototyping.
Certain engineering details, specifications, and implementation aspects have been intentionally abstracted or withheld due to intellectual property, regulatory, and confidentiality considerations.
48%
of patients stop using
existing devices within 3 months
1.8B
USD wearable NMES
market value
Class IIa
EU MDR regulatory
target
Design as the primary risk control​
​All identified risks were mitigated through industrial design decisions — not afterthought safety features. Standards considered: IEC 60601 series, IEC 62366-1, ISO 14971, ISO 10993, ISO 13485.
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