Rigorous, Trusted Medical Device Testing
For the reliability, precision and durability to help keep patients safe, we consider medical device testing a purpose and a passion. NTS has extensive experience supporting the invasive and non-invasive medical products market. As technology advances and medical equipment continues to progress in its capabilities, the need for testing will only increase.
NTS works with medical device manufacturers to determine the testing needed to meet FDA, product safety, and other essential certifications to bring products to market quickly. Even in cases where no testing protocol has been established, NTS engineers can help you focus on the most beneficial testing for your product development process. Medical device testing and engineering services include:
- EMC, EMI Testing and Pre-scanning
- Global Market Access and International Approvals
- Product Safety Testing and CE Marking
- FDA Coexistence Testing
- Electronics Reliability and Materials Testing and Evaluation
- Environmental Testing
- Root Cause Failure Analysis
- Durability Testing
- Chemical Exposure Testing
Our comprehensive experience gives us the ability to develop programs that combine many of these tests. Many of our medical sector customers come to us for EMC testing and opt to include the global approvals required for their products end market.
Ensuring Electromagnetic Compatibility (EMC) of Medical Devices
NTS operates more than 50 chambers across the US and Canada, ranging in size three meters to 10 meters. We also offer EMC pre-compliance scans, electrostatic discharge (ESD), radiated RF immunity, electrical fast transients, surge, conducted immunity, magnetic H-fields, voltage dips and interrupts, radiated and conducted emissions, harmonics and flicker.
FDA EMC Recognized Standards include:
- IEC 60601-1-1 – Medical Equipment Part 1 – 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
- 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 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 level of performance you need in your medical device software and hardware. NTS is here to help you achieve it, with certification USB, FDA coexistence, software compatibility and interoperability, functionality, performance and usability testing for monitors, handheld electronic devices, computers and peripherals and more.
The primary areas of scrutiny for FDA Guidance regarding medical/wearable devices are:
- Wireless coexistence
- Data integrity
Rest assured, 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.
- RF, ESD, Immunity, Package, Radiated Emissions, RE, Shock, Temp, Drop and Environmental testing for large surgical systems.
- Ingress protection (IP) and engineering pre-scan of a li-ion batteries.
- Blowing sand, dust and rain, ingress, shock and vibration of remote and Wi-Fi patient monitoring systems.
- Acoustic noise testing, pull testing, sound testing, temperature and abrasion testing of breast pumps.
- Environmental testing of patient temperature management devices.
- Altitude testing on respiratory ventilators.
- Noise testing of blood gas analyzers.
- Enclosure protection of Bluetooth medication trackers.
- Shock and vibration of infusion pumps.
- Vibration testing of workstation carts, cables, microscopes and pumps.
- Environmental exposure and durability testing of medication delivery systems such as IV pumps.
Is it Tough Enough? Materials Testing for Your Medical Device
From thermoplastics to adhesives, composites to glass, thermosets to titanium, implantable or 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.