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A Higher Standard for Medical Testing
GVIRL employs the world’s top thought leaders in medical device and equipment testing. With best-in-class queue times and on-time reporting, GVIRL goes above and beyond to help customers meet global requirements to bring products to market quickly. Plus, customers get a single-point-of-contact to make it easy to get products into more than 180 international markets.
GVIRL provides custom testing to meet FDA, product safety, and other essential certifications to bring products to market quickly.
- 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
GVIRL 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, GVIRL adheres to a higher standard. As technology continues to advance and medical equipment evolves, GVIRL remains one step ahead, always providing customers with the latest and most rigorous testing requirements.
GVIRL 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.
28 Labs in North America
Leveraging 28 labs in North America, GVIRL provides medical device and equipment manufacturers with unmatched technical expertise at convenient locations. With GVIRL on your side, you get:
- On-Time Test Reports
- Cost Management
- Open Communication
- Expedited Scheduling
Remote Test Witnessing
Keeping you on schedule is a priority—regardless of circumstance. Whether it’s due to COVID-19 or budgetary considerations, GVIRL provides remote test witnessing. With this service, you’re able to view testing on a laptop, tablet, or smartphone from the comfort of your home. Take a moment to explore the interactive explanation about how you can get safe, secure, and effective remote testing services from anywhere.
Accelerated Market Entry
Getting to market quickly is a priority. The Fast Track program is designed to give customers access to expedited scheduling. And with the Committed Service Delivery initiative, all customers receive test reports on a guaranteed date. With best-in-class que times and expedited scheduling options, GVIRL is able to help customers receive testing early than the competition to facilitate accelerated market entry.
Electromagnetic Compatibility (EMC) of Medical Devices
GVIRL operates the most EMI/EMC chambers in the Western Hemisphere. GVIRL labs are equipped with chambers that range from three to 10 meters—and are able to perform all EMI/EMC-related services, including 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. Common standards include the following:
- 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
RFID 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. GVIRL 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 EMI/EMC and RF Testing
GVIRL has collaborated with leading companies to execute EMC compliance testing on a wide variety of medical devices and equipment. Some examples include:
- Ventilators
- 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. GVIRL 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
- EMI/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. GVIRL 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.
GVIRL can add environmental testing to your EMC testing programs for a more complete evaluation of your product. Some examples of environmental testing for medical devices includes the following:
- 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
Robust ISTA and ASTM Packaging Testing
Medical equipment must arrive at its final destination unharmed. As a result, GVIRL takes significant precautions to make sure your package can withstand the rigors of domestic and international travel. Take a moment to view the animation below to see how ASTM and ISTA testing can protect your package against temperature, humidity, and physical damage.
Materials Testing for Medical Devices
From thermoplastics to adhesives, composites to glass, thermosets to titanium, implantable devices, printed circuit boards, electronic components and more, GVIRL 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 GVIRL ensures that you put only healthy, strong and reliable medical devices on the market fast.