Comprehensive Medical Device Testing for Regulatory Compliance
Compatible Electronics provides comprehensive testing services for medical devices. As an FDA ASCA recognized laboratory, we ensure your medical devices meet safety, EMC, and performance requirements for regulatory compliance worldwide.
Comprehensive Medical Device Testing
Medical device testing ensures your products meet stringent safety and performance standards required by regulatory agencies including FDA, European Union, and other global markets. Our testing services cover electrical safety, electromagnetic compatibility, usability, and specialized requirements for various device types.
Our Testing Capabilities
Electrical Safety Testing
- IEC 60601-1 Medical Equipment Safety
- IEC 61010-2-101 IVD Equipment Safety
- ANSI/AAMI ES60601-1 US National Differences
- Leakage current measurements
- Dielectric strength testing
EMC Testing
- IEC 60601-1-2 Medical Device EMC
- IEC 61326-2-6 IVD Equipment EMC
- Emissions and immunity testing
- Essential performance verification
- Wireless coexistence evaluation
Specialized Testing
- IEC 60601-1-6 Usability Testing
- IEC 60601-1-8 Alarm Systems
- IEC 60601-1-11 Home Healthcare
- Risk management integration
- Biocompatibility coordination
Particular Standards
- IEC 60601-2-2 Surgical Equipment
- IEC 60601-2-4 Defibrillators
- IEC 60601-2-12 Ventilators
- IEC 60601-2-24 Infusion Pumps
- Many other particular standards
Medical Device Categories We Test
Diagnostic Devices
- Patient monitors
- Diagnostic imaging equipment
- IVD analyzers
- Point-of-care devices
Therapeutic Devices
- Infusion pumps
- Ventilators
- Defibrillators
- Surgical equipment
Life-Supporting
- Critical care ventilators
- Cardiac equipment
- Anesthesia systems
- Emergency devices
Home Healthcare
- CPAP devices
- Home monitors
- Wearable devices
- Diabetes management
FDA ASCA Recognized Laboratory
Our FDA ASCA Recognition
- TL-80: IEC 60601-1 Electrical Safety Testing
- TL-81: IEC 60601-1-2 EMC Testing
- TL-82: IEC 61010-2-101 IVD Equipment Safety
FDA accepts our test reports without additional review - faster path to 510(k) clearance
Accreditations & Certifications
NVLAP Accreditation
- Lab Code 200527-0
- ISO/IEC 17025:2017
- Regular audits maintained
FDA ASCA Program
- Three testing laboratories
- Streamlined FDA review
- Reduced submission delays
Global Standards
- IEC international standards
- EN European harmonized
- ANSI/AAMI US standards
Quality Management
- ISO/IEC 17025 compliant
- Rigorous test procedures
- Comprehensive documentation
Ready to Get Your Medical Device Tested?
Contact our experts today for comprehensive medical device testing services.
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