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.
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.
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
Our laboratories support comprehensive testing for maritime and offshore technologies:
Worldwide approval
on wireless products and products with wireless interfaces
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Radiated and conducted interference immunity
Conducted immunity
Fast transients (burst)
Emissions measurement
from 20 Hz to 750 GHz
Immunity tests
Conducted disturbances
according to ISO/IEC 17025:2017
Analysis of harmonic currents
according to EN 61000-3-2
High-frequency electromagnetic fields
26 MHz to 6 GHz
Document review
Examination of the accompanying documentation in accordance with EN/IEC 60601-1-2
Flicker measurement
according to EN 61000-3-3
Discharge of static electricity
Complementing our core testing capabilities, we offer:
Global Approval
International Type Approval
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Collaboration
On-site in our laboratory
Seminars and Training
for a deeper understanding of complex topics
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Project Management
for More Complex Projects
Monitoring
Precise monitoring for reliable test results
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Logistics and Warehousing Services
For the safe transport of your test devices
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Advisory
For greater expertise and support
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Our experts are happy to assist you. Let’s work together to determine the next steps.
Graduated Project Engineer
