Save up to 60% on IEC 60601 & EMC testing costs– without compromising quality.
Get your personalized cost estimation in minutes and start testing in just 2 weeks instead of 9 months.
Free · No documents required · Takes about 60 seconds
Smarter medical device testing starts with transparency.
Get an instant indicative testing cost using our AI-assisted estimator, based on your required standards and real laboratory pricing.
ISO/IEC 17025-accredited laboratories
Testing slots from ~2 weeks
International laboratory network
CB Scheme support available
Key Benefits
Safe up to 60% on device safety testing costs
Real Testing Project Examples
Real anonymized project examples. Final pricing depends on device configuration, applicable standards, target markets and final laboratory scope.
Scope
IEC 60601-1 · IEC 60601-1-2 · IEC 60601-1-8 · IEC 62366-1 · IEC 62304 · EN 80601-2-58 · EN 300 328
German Lab Quote: €73,000
EU scope only
SMeDicC Partner Lab: €43,000
EU + US scope
Savings: €30,000 (~41%)
with a broader market scope
Scope
IEC 60601-1 · IEC 60601-1-8 · Usabillity · IEC 62304 · IEC 60601-2-2 · IEC 80601-2-58 · IEC 60601-1-9 · ETSI Radio/EMC · CB
German Lab Quote: €170,000
SMeDicC Partner Lab: €54,000
Savings: €116,000 (~68%)
How It Works
Why these tests are essential
To sell your medical device in Europe, the USA, UK, Switzerland or all over the world, you need to prove compliance with strict international standards. This typically includes:
IEC 60601-1 – Electrical safety
IEC 60601-1-2 – Electromagnetic compatibility (EMC)
IEC 60601-1-6 – Usability engineering
IEC 60601-1-8 – Alarm systems
IEC 60601-1-11 – Home healthcare environments
Other IEC 60601-2-x particular standards for specific device types (e.g. ventilators, monitors, pumps)
Compliance is verified through testing by accredited laboratories, followed by the issuance of test reports.
Test Report vs. CB Report – What’s the difference?
A Test Report is a technical document confirming your product passed a specific test according to the relevant standard. It is often sufficient for internal files and CE marking.
CB Report & Certificate
A CB Test Report (CBTR) documents testing performed against the applicable IEC standards within the IECEE CB Scheme.
Together with the corresponding CB Test Certificate, it can support international market access and reduce the need for repeated testing in participating countries.
Whether a CB Scheme package is appropriate depends on your target markets and certification strategy.
Key Benefits: Why work with SMeDicC?
SMeDicC combines regulatory expertise with a global lab network to reduce testing cost while maintaining full compliance. Here’s how we’re different:
Accredited partner labs certified to ISO/IEC 17025 and comparable in quality to TÜV SÜD or TÜV Rheinland Germany
Independent price estimation using AI – fast, realistic, tailored
Regulatory guidance & project support throughout your testing journey
Transparent pricing, no hidden fees,
Real-world experience with complex active devices, wireless modules, and multi-market strategies
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