Electrical Hazards
Insulation integrity, protective earth connections, leakage current limits
Medical device manufacturers face stringent regulatory requirements across electrical safety, electromagnetic compatibility, and wireless certification. MiCOM Labs delivers A2LA-accredited testing services under ISO/IEC 17025 that help connected medical devices, diagnostic equipment, and laboratory instruments meet global compliance requirements efficiently.
MiCOM Labs provides end-to-end testing for medical devices requiring regulatory clearance across multiple jurisdictions. Our A2LA accreditation (Certificate #2381.01) ensures test results meet the documentation standards required for FDA, Health Canada, and European regulatory submissions.
Electromagnetic compatibility testing validates that medical devices operate reliably in clinical environments without causing or experiencing harmful interference.
| Test Type | Application | Standard |
|---|---|---|
| Radiated Emissions | Prevents interference with nearby medical equipment | IEC 60601-1-2, EN 55032, FCC Part 15 |
| Conducted Emissions | Eliminates power line interference in healthcare facilities | IEC 60601-1-2, EN 55032, ICES-003 |
| Harmonic Current Emissions | Protects power grid stability in hospitals | IEC 61000-3-2, IEC 60601-1-2 |
| Voltage Fluctuations | Maintains power quality for life-supporting equipment | IEC 61000-3-3, IEC 60601-1-2 |
Prevents interference with nearby medical equipment
IEC 60601-1-2, EN 55032, FCC Part 15Eliminates power line interference in healthcare facilities
IEC 60601-1-2, EN 55032, ICES-003Protects power grid stability in hospitals
IEC 61000-3-2, IEC 60601-1-2Maintains power quality for life-supporting equipment
IEC 61000-3-3, IEC 60601-1-2| Test Type | Application | Standard |
|---|---|---|
| Radiated Immunity | Ensures device function during RF exposure from wireless equipment | IEC 61000-4-3, IEC 60601-1-2, EN 55035 |
| Conducted Immunity | Validates operation during power line disturbances | IEC 61000-4-6 |
| ESD Immunity | Prevents system failure from static discharge in clinical settings | IEC 61000-4-2 |
| Surge Immunity | Protects against transient-induced failures | IEC 61000-4-5 |
| Electrical Fast Transients | Maintains function during switching events | IEC 61000-4-4 |
| Voltage Dips and Interruptions | Ensures operation during power supply variations | IEC 61000-4-11, IEC 61000-4-29 |
Ensures device function during RF exposure from wireless equipment
IEC 61000-4-3, IEC 60601-1-2, EN 55035Validates operation during power line disturbances
IEC 61000-4-6Prevents system failure from static discharge in clinical settings
IEC 61000-4-2Protects against transient-induced failures
IEC 61000-4-5Maintains function during switching events
IEC 61000-4-4Ensures operation during power supply variations
IEC 61000-4-11, IEC 61000-4-29Medical devices require electrical safety verification across multiple hazard categories. MiCOM Labs performs comprehensive testing in accordance with IEC 60601-1 for medical electrical equipment.
Insulation integrity, protective earth connections, leakage current limits
Equipment stability, moving parts, resistance to mechanical stress
Temperature-rise testing, accessible surface limits, and heat-related ignition prevention
Material evaluation, insulation systems, fire propagation control
Optical radiation limits, acoustic pressure levels, and ionizing radiation sources
Liquid exposure protection, contamination prevention, and cleaning fluid resistance
Wireless medical devices require regulatory approval across target markets. MiCOM Labs provides RF testing and certification for medical technologies using Wi-Fi, Bluetooth, cellular, Zigbee, LoRa, and RFID.
Frequency range up to 220 GHz
FCC Part 15, Part 18, Part 27 compliance
ISED RSS compliance
EU RED radio equipment testing
UKCA compliance
MIC Japan type approval
Antenna performance evaluation
MiCOM Labs holds direct certification authority across five major regulatory markets, eliminating delays from third-party review processes. Additional market access extends through APEC TEL MRA Phase I recognition and bilateral agreements.
| Market | Regulatory Authority | MiCOM Labs Role |
|---|---|---|
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United States
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FCC | Telecommunication Certification Body (TCB) |
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Canada
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ISED | Foreign Certification Body (FCB) |
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European Union
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CE | Notified Body under US-EU MRA |
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United Kingdom
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UKCA | Approved Body under US-UK MRA |
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Japan
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MIC | Registered Certification Body (RCB) |
MiCOM Labs' proprietary platforms streamline the testing and certification workflow, reducing time-to-market for medical device manufacturers.
Automates test execution, provides live project status, and allows access to provisional results before final reports.
End-to-end workflow management for certification applications, tracking status, documentation, and automated alerts.
Centralizes compliance documentation, securing test reports, certification records, and renewal schedules for faster regulatory responses.
MiCOM Labs follows a structured sequence to ensure accurate testing and timely certification.
Equipment specifications reviewed, user manuals evaluated, applicable standards identified
Detailed test protocol developed, sample requirements documented, timeline estimated
Electrical safety verification, EMC evaluation, RF compliance testing, environmental validation
ISO/IEC 17025-compliant test reports issued, compliance determinations documented
Applications submitted to regulatory authorities, status tracking via MiCMS®, and declarations of conformity issued
Equipment specifications reviewed, user manuals evaluated, applicable standards identified
Detailed test protocol developed, sample requirements documented, timeline estimated
Electrical safety verification, EMC evaluation, RF compliance testing, environmental validation
ISO/IEC 17025-compliant test reports issued, compliance determinations documented
Applications submitted to regulatory authorities, status tracking via MiCMS®, and declarations of conformity issued
In vitro diagnostic systems, clinical chemistry analyzers, and hematology instruments require comprehensive testing before regulatory approval. MiCOM Labs evaluates laboratory automation systems and sample handling equipment against applicable safety and EMC standards.
Wireless patient monitors, remote diagnostic equipment, and telehealth systems need RF compliance certification. Testing covers wireless performance, electromagnetic compatibility, and electrical safety requirements.
Medical imaging accessories, laboratory test equipment, and diagnostic analyzers require testing to validate safety compliance and electromagnetic compatibility in healthcare environments.
Universities, government laboratories, and private research facilities use specialized measurement equipment that requires certification before it can be used, approval from the institution, and acceptance by regulators.
MiCOM Labs provides comprehensive testing services from a single A2LA-accredited facility.
A2LA-accredited electromagnetic compatibility and interference evaluation
Up to 220 GHz frequency range
2D/3D radiation patterns, gain measurement, efficiency analysis
Temperature cycling, humidity exposure, vibration testing
EU RED Article 3.3 compliance for connected devices
MiCOM Labs is an A2LA-accredited testing laboratory (ISO/IEC 17025, Certificate #2381.01), ensuring that results meet documentation and traceability standards required for regulatory submissions to the FDA, Health Canada, and European authorities. Founded in 2001 by Gordon Hurst, the company brings over 25 years of experience in wireless, EMC, and safety testing for medical devices, automotive systems, and aerospace equipment across complex regulatory frameworks.
With headquarters in Pleasanton, California, and offices in Shenzhen, China, and India, MiCOM Labs combines global reach with local regulatory expertise. The MiComms™ platform keeps manufacturers up to date on evolving safety standards and regulatory changes, enabling teams to proactively adjust compliance strategies and maintain uninterrupted certification workflows.
MiCOM Labs designs test protocols that exercise device functions under stress. This includes validating response times under interference conditions and testing at levels exceeding standard requirements when applications demand greater resilience.
IEC 60601-1-2 mandates EMC testing for medical electrical equipment. IEC 60601-1 requires electrical safety testing. Additional standards apply based on device type and intended use.
Yes. MiCOM Labs holds direct certification authority in the United States, Canada, the European Union, the United Kingdom, and Japan. For other markets, we coordinate with accredited local laboratories while managing project execution and regulatory submissions.
MiCOM Labs delivers A2LA-accredited testing services for medical device manufacturers navigating global compliance requirements. Our automated testing platforms and direct certification authority in major markets reduce time-to-market while ensuring regulatory acceptance.
Contact MiCOM Labs to discuss your device specifications, target markets, and testing requirements. Receive a detailed proposal outlining applicable standards, testing scope, and certification timelines.
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