MEDICAL DEVICE INSPECTION, TESTING & FAILURE ANALYSIS
From surgical tools to implantable devices, patients count on medical providers to use equipment that is safe, reliable, and free of contaminants. The medical industry counts on IIA to ensure just that. Clients ranging from start-ups to major manufacturers turn to IIA for inspection, testing, and failure analysis of Classes I, II, and III medical devices.
Offering state-of-the-art laboratories and a nationwide reach, our Lab Services division is well equipped to ensure mechanical integrity and safe material properties of your medical instruments and implant materials. Our capabilities include: Reverse Engineering, Comparative CAD Analysis, Dimensional Metrology, Laser & CT Scanning, Chemical Testing, Mechanical Testing, Metallurgical Testing, Non-Destructive Testing, and more. Our labs also feature EMI, EMC and Calibration capabilities.
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Material integrity is critically important in medical devices. Any failure calls for an urgent and thorough response to ensure the defect is corrected. Our team will provide the accurate results and the speed you need to get back on track quickly. We are equipped to provide an array of non-destructive and destructive tests to pinpoint the root cause of the failure and any contributing factors. Our deep understanding of testing and inspection — and state-of-the-art equipment — ensures highly accurate results. With decades of collective experience, our experts know which techniques will best meet your unique challenge.
Our expertise spans an array of laboratory non-destructive testing (NDT) methods — such as Ultrasonic Testing (UT) or Liquid Penetrant Testing (PT) — to examine and test the surface and subsurface without damaging the material. Our menu of services also includes: Digital and Conventional Radiography, CT Scan, Magnetic Particle Testing, Weld Inspection and Helium Mass Spectrometry.
Our deep understanding of testing and inspection — and state-of-the-art equipment — ensures highly accurate results. With decades of collective experience, our experts know which techniques will best meet your unique challenge.
Beyond the analysis, our team is available to develop a comprehensive corrective action plan to ensure that your medical product is 100% safe before it re-enters the market.
With an average of 25 years of experience, our skilled lab technicians provide highly accurate inspections and customer support throughout the product life cycle, start to finish. Our one-stop-shop services mean faster turnaround times, cost-effective solutions, and highly accurate results.
Partner with IIA Lab Services for:
- Faster turnaround times
- Accurate Data/ Reliable Results
- Cost Containment
- Responsive Customer Service
From product certification to failure analysis, we deliver the answers you need to move forward safely and with confidence.
We are ISO/IEC 17025: 2017 accredited for testing activities.
CHEMICAL ANALYSIS SERVICES
- Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES)
- Optical Emission Spectroscopy (OES)
- X-Ray Fluorescence Spectroscopy (XRF, PMI)
- Pyrolysis Gas Chromatography Mass Spectroscopy (PyGC/MS)
- Fourier Transform Infrared Spectroscopy (FTIR)
- Thermographic Analysis (TGA)
- Differential Scanning Calorimetry (DSC)
- Nickel Ion Release Testing
- Particulate Testing
- Phthalates and Latex
- CPSIA/CPSC Heavy Metals
METALLURGICAL TESTING SERVICES
- Failure Analysis
- Scanning Electron Microscopy (SEM)
- Energy Dispersive Spectroscopy (EDS)
- Coating/Plating Thickness and Evaluations
- Microstructure Analysis
- Grain Size
- Immersion Corrosion Evaluations
- Surface Roughness Measurement
WIRELESS & TELECOMMUNICATION EMC/EMI TESTING SERVICES
- EMF/RF Exposure & SAR testing
- Electrical/Product Safety Testing
- ISO/IEC 17065: 2012 Accredited Product Certification Body for U.S. FCC, ISED Canada, MIC Japan, IMDA Singapore. Notified/Approved Body (NB/AB1177) for the EU Radio Equipment and EMC Directives and the United Kingdom Radio Equipment and EMC Regulations.
MECHANICAL TESTING SERVICES
- Tension Testing (Tensile, Yield, Elongation, Reduction of Area, Modulus, Stain Hardening Exponent)
- Compression Testing
- Shear Testing
- Hardness (Rockwell, Brinell, Vickers, Durometer, Pencil, Leeb)
- Impact Testing (Charpy, Izod, Gardner)
- Tear Strength
- Flexural Properties
ENGINEERING SUPPORT SERVICES
- CT & Laser Scanning
- Part-to-CAD Comparison
- 3D Dimensional Inspection
- Geometry Recreation (Reverse Engineering)
DIMENSIONAL INSPECTION SERVICES
- First Article Inspection
- Capability Studies
- Supplier Validation (3rd Party Inspection)
- Mold & Fixture Evaluation
- CMM training on PCDMIS and Calypso
- FARO laser scanners training
Brochures & Summary Sheets
Certifications and Accreditations
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment. We are pleased to offer our expertise and can work closely with you on FCC or ISED communications regarding product certification. We have a deep understanding of the testing and inspection industry, and our experts are adept at knowing which modalities to use to provide a fast, viable, and high-quality solution to your challenge.
All inspectors are certified to one or more of the following:
- CQI (Certified Quality Inspector)
- CMI (Certified Mechanical Inspector)
- CQT (Certified Quality Technician)
- CQE (Certified Quality Engineer)
- CQM (Certified Quality Manager)
- CQA (Certified Quality Auditor)
- Duns Number:19-993-4829
- NAICS: 541380 (Mech. Testing Lab or Services)
- Cage Code: 0GB04
- SIC Code: 8734