Consider a wireless patient monitor: a few sensors, BLE radio, small display. Development and prototyping might run $45k.
Certification is another matter. FDA 510(k). IEC 60601 electrical safety. IEC 60601-1-2 EMC. Wireless certifications. Biocompatibility testing. Software documentation to IEC 62304.
Certification budget for this device: approximately $180k. Four times the development cost.
This ratio is common. For regulated products, compliance frequently exceeds engineering as the largest line item.
Where the Money Goes
Medical Devices (FDA 510(k) pathway)
| Category | Typical Cost |
|---|---|
| Predicate device research | $5-15k |
| Design controls documentation | $20-50k |
| Risk management (ISO 14971) | $15-30k |
| Software documentation (IEC 62304) | $25-60k |
| Electrical safety testing (IEC 60601-1) | $25-45k |
| EMC testing (IEC 60601-1-2) | $20-40k |
| Biocompatibility (ISO 10993) | $15-80k |
| Usability engineering (IEC 62366) | $10-25k |
| 510(k) submission preparation | $20-40k |
| FDA review fees | $15-20k |
| Total | $170-405k |
And that’s for a Class II device with a clear predicate. Class III or novel devices cost 2-5x more.
Wireless Products (FCC/CE)
| Category | Typical Cost |
|---|---|
| FCC Part 15 testing | $5-15k |
| FCC certification fees | $2-5k |
| CE RED testing | $8-20k |
| CE documentation | $3-8k |
| International certs (IC, MIC, etc.) | $3-10k each |
| Total | $21-58k |
Wireless adds cost everywhere. Each new market requires its own certification. A product sold in US, EU, Canada, Japan, and Australia might spend $80k+ just on radio certifications.
Industrial Equipment (CE/UL)
| Category | Typical Cost |
|---|---|
| CE LVD testing | $5-12k |
| CE EMC testing | $8-18k |
| CE documentation | $3-8k |
| UL/CSA listing | $15-40k |
| Functional safety (if applicable) | $30-100k |
| Total | $31-178k |
Why It Spirals
Scope creep through standards. One standard references another, which references another. IEC 60601-1 points to IEC 62368-1 for certain requirements, which points to other standards. You can end up buying $5k in standards documents just to understand what you’re required to do.
Testing failures. First-time pass rates for EMC testing are often around 60%. Each failure means redesign, retest. Budget for at least one round of rework.
Documentation requirements. Regulators want evidence. That means traceability matrices, design history files, risk analyses, test protocols, test reports. Documentation can take longer than the engineering work it documents.
Consultant dependency. Unless you’ve done this before, you’ll likely need regulatory consultants. Good ones cost $200-400/hour. They can be worth it, but the hours add up.
Lab scheduling. Accredited test labs book 4-8 weeks out. Rush fees add 50-100%. Your timeline gets held hostage by lab availability.
The Hidden Multipliers
Changes After Testing
Made a minor firmware update? Some certifications need to be repeated. Changed a component? Might need retesting. “Minor” changes cascade into major costs.
Multi-Region Sales
Every market has its own requirements:
- US: FCC, FDA (if medical), UL (if needed)
- EU: CE (RED, LVD, EMC, MDR if medical)
- Canada: ISED, Health Canada (if medical)
- Australia: RCM, TGA (if medical)
- Japan: MIC, PMDA (if medical)
- China: CCC, NMPA (if medical)
A global product launch can spend more on regulatory than on the entire engineering effort.
Ongoing Compliance
Certification isn’t one-time. Medical devices require:
- Annual registration fees
- Adverse event reporting systems
- Post-market surveillance
- Periodic audits
- Recertification when standards update
Budget 10-20% of initial certification cost annually for maintenance.
Planning for Reality
Early Regulatory Engagement
Bring in a regulatory consultant during the requirements phase, not after design is done. $5k in early advice can save $50k in redesign.
Design for Compliance
- Choose components with existing certifications
- Use pre-certified wireless modules
- Follow reference designs that have passed testing
- Build in design margin for EMC fixes
Pre-Compliance Testing
Do informal EMC and safety testing during development. Finding problems early is 10x cheaper than finding them at the certification lab.
Realistic Budgets
| Product Type | Development | Certification | Ratio |
|---|---|---|---|
| Simple consumer electronics | $30-60k | $15-30k | 0.5x |
| Wireless consumer device | $50-100k | $40-80k | 0.8x |
| Industrial equipment | $80-150k | $50-120k | 0.8x |
| Medical device (Class II) | $100-200k | $150-350k | 1.5-2x |
| Automotive component | $150-300k | $100-250k | 0.8x |
Medical devices frequently see certification exceed development. Other categories tend to stay below 1:1, but wireless and multi-region sales push the ratio up.
Timeline Reality
| Phase | Typical Duration |
|---|---|
| Development | 4-9 months |
| Pre-compliance testing | 2-4 weeks |
| Design fixes | 2-6 weeks |
| Certification testing | 4-8 weeks |
| Report preparation | 2-4 weeks |
| Regulatory review | 4-16 weeks |
| Total to market | 8-18 months |
The certification phase can take as long as development. For FDA submissions, regulatory review alone may exceed total development time.
When to Walk Away
Sometimes the math doesn’t work:
- If certification costs exceed your first-year revenue projection, reconsider the market
- If you can’t afford a failed test round, you can’t afford to certify
- If you’re entering a regulated market “to test demand,” budget for full compliance anyway
Compliance costs don’t scale with volume. A product selling 100 units and one selling 100,000 units pay the same certification fees. Low-volume products in regulated markets tend to be structurally disadvantaged.
The Bottom Line
Budget for certification from day one. Not as an afterthought. Not as a line item to cut when development runs over. As a core cost that will likely match or exceed engineering.
The companies that get this wrong run out of money between “working prototype” and “sellable product.” Don’t be one of them.
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