EMC Testing For Medical Devices
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Medical Device EMC Testing Services
We at H.B Compliance assist medical device businesses like yours in meeting demanding EMC testing regulations. Whether you’re getting ready for FDA clearance, CE marking, or simply need to ensure your device functions safely in the world at large, our experienced staff is available to assist.
We’re experts at EMC Compliance for Medical Equipment, so your gear won’t cause interference with other electronics—and won’t be the victim of interference, either. That will allow you to safeguard patients, build regulators’ confidence, and proceed with confidence.
What Is EMC Testing, and Why Does It Matter
EMC means Electromagnetic Compatibility. It is an indication of how well an apparatus can operate in its use without receiving or giving unwanted interference.
Take a hospital for example: dozens of equipment working together in perfect harmony with each other—infusion pumps, monitors, imaging equipment, ventilators, and so on. If one unit generates too much electrical noise or is too vulnerable to it, then the whole system breaks down. That’s where EMC testing of medical equipment saves the day.
It’s our responsibility to ensure your equipment complies with the regulations, functions correctly, and remains safe—regardless of what is around it.
We can offer EMI Testing for Medical Devices (electromagnetic interference testing) and have your product IEC 60601 EMC pass-tested, a critical feature for numerous medical devices.
Services We Offer
Our laboratory can offer all types of Electromagnetic Compatibility Testing for Medical Devices, which include:
Pre-Compliance Testing
We pretest the first batches of your product so that you don’t take the plunge until you have full certification. This keeps problems at bay before they cost you too much money out of your pocket.
Full EMC Compliance Testing
We test to international standards like FDA & CE Compliance Testing for Medical Devices. These include:
- Radiated and conducted emissions
- External disturbance immunity
- Power frequency magnetic fields
- Electrostatic discharge (ESD) testing
EMC Certification Reports
Obtain transparent, unambiguous test reports that will be accepted by regulators and certification bodies. We simplify the results and make them easy to understand in plain language.
Who We Help
We serve medical device firms of all sizes – start-ups and industry leaders. Whether you are developing a wearable, an implant, a diagnostic device, or patient monitoring device, we can assist.
Our EMC Lab for Healthcare Electronics is designed for the healthcare industry. We recognize the special safety requirements and stringent regulations your devices must comply with.
Why H.B Compliance?
We understand that this process can look daunting with all the technical jargon, standards, and paperwork. That’s why we make it simple:
Expert Assistance
Our firm is highly experienced in EMC and Medical Device Safety & EMC Certification. We spell it all out in simple terms and don’t waste time.
Quick Results
We know you’re busy. Our testing process is structured to give you quick results so you can get where you’re going on schedule.
Personalized Communication
No maddening reports to decipher or outrageous technicians. We’ll guide you through it and back you up in the process.
Industry Renowned
Our lab is reputed for reliable, honest results. American companies trust us to get compliant, safe products to market.
We’re Here to Help You Succeed
We’re just as dedicated to your product as you are. We understand: the work and know-how that go into making a medical device that performs and is safe—and we’re here to assist it in passing the tests that matter.
With our dependable Electromagnetic Interference Testing for Medical Equipment, clear reports, and sound counsel, you can proceed with confidence, no longer speculating if you’re going the right way.
Call us today at (480) 684-2969 to get started. Let’s get your device to market—safe, approved, and ready to make a difference.
Get in Touch
Frequently Asked Questions (FAQs)
Any medical device that uses electricity or electronics will most likely need EMC testing. That’s because equipment such as pumps, imaging equipment, implants, and even wearables utilize electricity and electronics. And if your device is to be used close to other electronics, EMC testing is generally necessary.
IEC 60601 is the world standard for the safety and performance of medical electrical equipment, and it has extremely stringent EMC requirements. If marketing in the U.S., Europe, or other regulated economies, your device probably needs to pass it.
Costs depend on the device type, complexity, and required standards. Some devices need just a few tests, while others need more extensive evaluations. We’re happy to provide a free estimate—just call us at (480) 684-2969.
This also differs with the device and number of tests to be conducted. All full EMC tests usually take 1–2 weeks. In case you do not have enough time, we can also perform expedited ones for accelerating the process.
Absolutely! Our staff has specialized in FDA & CE Compliance Testing of Medical Devices. We understand what every rule authority wants and can assist you with complete confidence that the requirements will be fulfilled.