Medical Technology

Validation for Medical Safety and Regulatory Compliance

Ensuring Accurate and Dependable Medical Systems

Medical devices must operate reliably under all conditions while protecting patients and users. We support testing for therapeutic devices, diagnostic equipment, and technical medical aids.

From prototype validation to production release, we provide standards-compliant, transparent, and technically precise testing.

Reliable testing. Regulatory confidence. Patient safety.


What We Test

Our laboratories support comprehensive testing for maritime and offshore technologies:

earth pin

Worldwide approval

For more information on wireless products and products with wireless interfaces

antenna

Radiated and conducted interference immunity

in the frequency range up to 6 GHz

cloud bolt

Fast transients (burst)

waveform lines

Emissions measurement

from 20 Hz to 750 GHz

bolt lightning

Immunity tests

plug

Conducted disturbances

according to ISO/IEC 17025:2017

bolt speed

Analysis of harmonic currents

according to EN 61000-3-2

magnet

High-frequency electromagnetic fields

26 MHz to 6 GHz

file content

Document review

Examination of the accompanying documentation in accordance with EN/IEC 60601-1-2

showers

Flicker measurement

according to EN 61000-3-3

bolt speed

Discharge of static electricity



Medical monitoring device

Expertise for Medical Electrical Equipment

Medical electrical equipment must comply with strict EMC and safety standards, particularly under EN/IEC 60601-1-2. Increasing connectivity, wireless integration, and digital system architecture introduce additional complexity.

Our team understands the interaction between EMC performance, electrical safety, wireless coexistence, and risk management requirements. We provide structured project coordination, detailed test documentation, and clear communication to support efficient regulatory approvals and market access.


Your Medical Testing Partner

With accredited laboratories and experienced project engineers, Testlab supports manufacturers in achieving:

  • Compliance with EN/IEC 60601 series requirements
  • Reliable EMC performance in clinical environments
  • Safe integration of wireless technologies
  • Transparent documentation for regulatory submissions
  • Efficient approval processes for international markets

 

Discuss your requirements with our specialists and define the right next steps for your project.

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