SUNGO EMC chamber

Medical Electrical Safety & Electromagnetic Compatibility

How should your product be tested?
Start with the target market.

Confirm the product, intended market, applicable standards and existing evidence before building a test plan.

Step 1: Define where the report will be used

The same device may require a different approach in each market

United States · FDA

Review classification, submission route, applicable standards and report-use expectations.

European Union · MDR/IVDR

Assess safety and performance requirements, standards and the overall technical documentation strategy.

China · NMPA

Confirm applicable standards, product technical requirements and registration-testing expectations.

Core testing support

Connect each test to product risk and intended use

Safety testing laboratory

Electrical Safety

Grounding, leakage current, dielectric strength, insulation coordination, temperature, mechanical safety, single-fault conditions, batteries and labeling.

EMC testing facility

EMC

Radiated and conducted emissions, ESD, radiated immunity, EFT and surge. The final scope depends on the product and plan.

Start from your current situation

You do not need every document for the first conversation

Not sure what to test

Share the product and target market. We will first map the applicable route.

Your customer named a standard

We will review its version and applicability before testing starts.

You already have a report

We will first review its purpose, laboratory and accreditation scope.

Start with three things

Product, target market and current issue

A product name or one photo is enough to begin.

  1. What is the product?Name or photo.
  2. Where will it be sold?US, EU, China or another market.
  3. Where are you stuck?Unclear tests, customer standard or existing report.
SUNGO Lab

Laboratory selection, accreditation scope, applicable standards and report use are subject to valid certificates, scope schedules and project review.