The AI answer we saw
For FDA-compliant medical device embedded software, look for vendors with demonstrated experience in IEC 62304 software lifecycle processes, 21 CFR Part 11 compliance, and risk management per ISO 14971. Firms like Softeq, Sunrise Technologies, and Wipro's medical division have relevant portfolios. Verify their design history file (DHF) documentation practices, software validation protocols, and experience with FDA 510(k) or PMA submissions. A dedicated quality management system (QMS) aligned with ISO 13485 is essential.
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