Medical Electromagnetic Compatibility (EMC) evaluates a product to determine if it is compatible with its intended electromagnetic environment(s). Will it interfere with other nearby products and/or will it be negatively impacted by other nearby products?
In Healthcare applications EM incompatibility and medical device electrical safety is not just a nuisance, it is potentially life-threatening. Most global regulatory bodies recognize a product cannot be safe and effective if it is not also compatible with its intended electromagnetic environment.
Medical Device Safety Testing, IEC 60601 Testing, and Risk Management
For medical products, IEC 60601-1-2 4th edition has significant changes that impact both medical device safety testing, IEC 60601 testing, and risk management related to basic medical device electrical safety and essential performance. On December 31, 2018 this standard becomes mandatory for new product submittals to the US FDA and medical products entering the European Union. This standard requires that risks resulting from reasonably foreseeable electromagnetic disturbance be taken into account in the risk management process and references ISO 14971 (Medical Devices – Application of Risk Management to Medical Devices).
Full Compliance Medical Device Safety Testing to Global EMC and Wireless Requirements
- Medical Electromagnetic Compatibility (EMC) Risk Management Evaluation to IEC 60601-1-2 4th Edition – We can assist with this portion of evaluation even if you decide to use your favorite “local” EMC lab.
- CB Certification to IEC EMC and Safety Standards for medical device electrical safety
- Pre-Compliance Services including Risk Management, Test Plan and Instruction for Use review as part of full IEC 60601-1-2 4th Ed projects
- Preliminary EMC Testing Services
- GAP Analysis – Review of existing documentation/reports to latest requirements for medical device electrical safety
- Technical Assistance Program (“rent an engineer”) – Time with one of our experts
- Wireless Global Market Access (GMA) Services
- Telecommunication Certification Body (TCB) for the U.S. Federal Communications Commission
- Foreign Certification Body (FCB) for Canada
- Conformity Assessment Body (CAB) – Notified Body for the European Union
- SAR (Specific Absorption Rate) Testing
|Global Market Acceptance
||Comprehensive Testing & Certification Services
|Knowledge of Global Standards and Regulatory Requirements
||State of the Art Facilities