Product Overview
Medical Device Development for Startups
For founders who need a first device to show investors, run a clinical study or get to a 510(k). We start with a discovery phase that turns the idea into requirements, an architecture and a phase plan with hours, so the budget and timeline become firm numbers in the contract. Then we answer the riskiest technical question first, build prototypes and a golden sample, and prepare the engineering side of the submission: design history file, risk management inputs and verification reports.
From idea to design for manufacturing usually takes 6 to 12 months, and small projects run 2,000 to 3,000 engineering hours. One published rate of $125 per hour. If something we designed doesn't work as specified, we fix it at our cost.
220 medical devices developed since 2015 by a team of 62 engineers under an ISO 13485:2016 certified quality system.
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