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Medical Device Firmware Development India: IEC 62304 Cost & Timeline

5 min read

Medical device firmware in India must follow IEC 62304 and support your regulatory submission (CDSCO, FDA, CE). Cost and timeline in 2026.

Device complexity, risk class, and documentation depth. Simple diagnostic or monitoring: ₹12–25 lakh, 12–18 weeks. Complex or Class III–related: ₹25–50 lakh+, 18–26 weeks.

Requirements, design, implementation, verification and validation, traceability matrix, and software documentation package for auditors. We follow IEC 62304 lifecycle. At Hendoi we develop medical device firmware for India, USA, and Canada. Contact us for a scoped quote.

📞 +91-9677261485 | 📧 support@hendoi.in | Contact us

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