Trusted Medical Device Testing

NTS has extensive experience supporting the invasive and non-invasive medical products market. For the reliability, precision and durability to help keep patients and users safe, we consider medical device testing a purpose and a passion. And as technology  advances and medical equipment continues to evolve, the need for professional and expert testing will only increase.

Rest assured, we will be ready. NTS works with medical device manufacturers to perform the testing needed to meet North American, European, and other international markets for product quality, regulatory compliance, and agency certifications to help bring products to market quickly and cost effectively. Even in cases where no testing protocol has been established, our engineers can help you focus on the most beneficial testing for your product development process.  Medical device testing and engineering services include: 

Our extensive network of professionals and lab resources gives us the unique ability to develop programs that provide the most beneficial and cost effective solutions available in the industry. Many of our medical sector customers choose to work with us because of our reputation and premier EMC lab capabilities. From those platforms, our clients often take advantage of other services to help meet their global and product development plans.

Electromagnetic Compatibility (EMC) of Medical Devices

NTS operates more than 50 chambers across the US and Canada, ranging in size

from small three (3) meters to 10- meters and bigger for unique projects. East facility is fully equipped to perform all other EMC services, such as pre-compliance scans, electrostatic discharge (ESD), radiated RF immunity, electrical fast transients, surge testing, conducted immunity, magnetic H-fields, voltage dips and interrupts, radiated and conducted emissions, harmonics and flicker, and more as your particular project requires.

Common EMC Recognized Standards include:

  • IEC 60601-1-2– Medical Equipment Part 1 – 2: General Requirements for Basic Safety and Essential Performance – Requirements and Tests
    • Plus EN/IEC 606001-2-xx for particular devices as applicable
  • ANSI / RESNA WC2 – Standard for Wheelchairs – Volume 2: Additional Requirements for Wheelchairs (including scooters) with Electrical Systems.
  • ANSI C63.19, Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
  • Applicable FCC Standards
    • FCC Part 15 Radio Frequency Devices
  • Part 15 Subpart B: Unintentional Radiators
  • Part 15 Subpart C: Intentional Radiators
  • Part 15 Subpart D: Unlicensed Personal Communications Service Devices
  • Part 15 Subpart E: Unlicensed National Information Infrastructure Devices

Essential Testing of Radio Frequency Identification (RFID) of Medical Devices

What would hospitals and healthcare facilities do without RFID? Today, it is the go-to technology for inventory and equipment tracking; making the important job of matching patients to the right medications faster and more accurate than ever. As this technology and its applications grow, so too does the need for understanding its potential for interfering with other electronic medical devices like pacemakers.

Our medical device testing facilities perform RFID susceptibility testing to expose any RFID emissions any RFID issues your product might have.

And with the expansion of radio frequency (RF) wireless technologies, it is imperative that your wireless medical device peacefully coexist with other wireless devices in a hospital, doctor’s office, clinical environment, or in the patient’s home. NTS can evaluate your FDA Wireless Coexistence testing needs, develop a test plan, and work with you to submit results to the FDA for review and approval.

Medical Device EMC and RF Testing Down to the Finest Detail

NTS has collaborated with leading companies to execute EMC compliance testing on a wide variety of medical devices and equipment. Some examples include:

  • Light Therapy Devices
  • Surgical Microscopes
  • Eye Scanning Analysis Tools
  • Muscular Stimulation Devices
  • AED Devices
  • Glucose Monitors
  • Repeater Pumps
  • UV Blood Sterilizers
  • Medical Waste Disposal Devices
  • Electric Wheelchairs
  • Large and Small Surgical Systems and Devices

Focused Medical Technology Testing

Perfection is the only level of performance you need in your medical device software and hardware. NTS is here to help you achieve it, with certification programs, FDA requirements, software compatibility and interoperability, functionality, performance and usability testing for all types of devices ranging from monitors, handheld electronic devices, computers and peripherals, and more. 

The primary areas of scrutiny for FDA Guidance regarding medical/wearable devices are:

  • Wireless Coexistence
  • Performance
  • Data Integrity
  • Security
  • EMC

Our highly skilled engineers focus on identification, documentation and implementation of product design requirements (21 CFR 820.30), as well as design verification and validation (21 CFR 820.30) and risk management process and procedures.

NTS will prepare a customized test plan, execute the testing, and assist with submission for FDA approval.

Medical Device Environmental Testing

Environmental testing for medical devices covers a wide variety of test disciplines. Our engineers can help you determine the best environmental tests for your medical product depending upon its end use.

As we do for many medical device partners, NTS can add environmental testing to your EMC testing programs for a more complete evaluation of your product. Some examples of environmental testing medical devices includes:

  • Altitude, humidity, vibration, susceptibility, drop, ingress, EMC, and vibration of an AED device
  • Anechoic chamber testing, shock and load, slow thermal cycle and damp heat testing, vibration, bump and shock on surgical microscopes
  • Package testing, random vibration, shipping and altitude testing conducted on heart pump control units
  • Altitude, humidity, vibration, susceptibility, drop, ingress, EMC, and vibration of an AED device
  • Anechoic chamber testing, shock and load, slow thermal cycle and damp heat testing, vibration, bump and shock on surgical microscopes
  • Package testing, random vibration, shipping and altitude testing conducted on heart pump control units

Is it Tough Enough? Materials Testing for Your Medical Device

From thermoplastics to adhesives, composites to glass, thermosets to titanium, implantable devices, printed circuit boards, electronic components and more, NTS can test it. Reliability and product comparison studies are routinely conducted and can be important evaluative tools for medical devices. Materials testing encompasses:

  • Root cause failure analysis of medical electronics and non-electronic device field returns
  • Component analysis, standard radiography, and computer tomography (CT) of hearing implants
  • Contamination analysis of handheld wireless diagnostic tools
  • Mechanical properties (tensile, flexure, compression, hardness, etc.) of non-electronic devices
  • Cleanliness testing of surgical tools
  • Cleaning procedure validation of endoscopes

Find out how NTS ensures that you put only healthy, strong and reliable medical devices on the market fast. Request a Quote today.

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