IEC 62304 Implementation Fee
Implementing IEC 62304 requires a significant investment of time and resources. Understanding the roles of consultants and software developers, and the associated costs, is crucial for medical device manufacturers seeking to achieve and maintain compliance. By carefully planning the implementation process, selecting qualified consultants and software developers, and fostering effective collaboration, manufacturers can minimize the cost and risk of IEC 62304 compliance and ensure the safety and effectiveness of their medical device software.
Collaboration Between Consultants and Software Developers
Effective collaboration between consultants and software developers is essential for a successful IEC 62304 implementation. Consultants provide guidance and expertise on IEC 62304 requirements and processes, while software developers implement those processes and ensure that the software meets the specified requirements.
IEC 62304 Consulting Fee
| Category | Class | Fee (USD) |
|---|---|---|
| Software Developer (SAMD) | Class A | $8,000 |
| Class B | $12,000 | |
| Class C | $16,000 | |
| Software Developer (SIMD) | Class A | $6,000 |
| Class B | $8,000 | |
| Class C | $11,000 | |
| Integration with EN ISO 13485:2016 | $10,000 | |
| Integration with QMSR / 21 CFR 820 | $10,000 | |
| Integration with ISO 13485 and QMSR | $10,000 | |
| Integration with MDSAP | $10,000 | |
🌟 Special Pricing & Smart Savings
⊗ A 30% discount provided when it’s combined with MDR or IVDR or 510k Service request.
⊗ Enjoy an additional 10% discount when client software development team coordination with I3CGlobal team is excellent and implementation successfully completed within 4 months.
⚠️ Items Excluded / Subject to Additional Fees
⊗ The above pricing applicable for offsite implementation.
⊗ Any travel to customer location will be charged extra on actual expense plus a daily allowance of 600 USD. Consultants are based in India, Chicago, and London.