Failure Mode & Effects Analysis for Medical Devices
Material integrity is of great importance within consumer products, parts, and components but could not be any more important than in the medical devices industry, especially for implantable medical devices.
Unfortunately, sometimes things do go wrong, and when they do, it is imperative to have a corrective action plan with a trusted and knowledgeable industry leader who has the expertise, laboratory professionals, and equipment, to perform Failure Mode & Effects Analysis (FMEA) and provide accurate and fast results so you can get back on track.
When it comes to medical devices, the failures could include a number of reasons, such as materials, chemistry, or sensitivity and to determine the exact cause of the failure, a myriad of testing is sometimes needed.
One important aspect of FMEA is Non-Destructive Testing (NDT), which is used to identify defects in material without causing damage, or destruction, to the material. Varying methods are used in the lab to examine and test the surface and subsurface of the material, such as Ultrasonic Testing (UT) or Liquid Penetrant Testing (PT), and our team also provides Digital and Conventional Radiography, CT Scan, Magnetic Particle Testing, Weld Inspection and Helium Mass Spectrometry.
It is important to note that when a failure occurs, the answer is Failure Mode & Effects Analysis to ensure the defect and failure are corrected and the product is 100% safe before it re-enters the market.
IIA’s experts are determined to help you examine your parts, components, and devices and provide you with reliable results and actionable reports to help you create a plan to move forward in order to make changes and return to production to ensure a safe and compliant product is back on the market.
We are the trusted partner for a highly regulated industry. Medical Device Inspection, Testing, and Failure Analysis for Classes I, II, and III, without ever compromising quality. We have state-of-the-art laboratories and a Nationwide reach, and 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 have EMI, EMC and Calibration capabilities.
Our experts are knowledgeable and responsive and provide full product life cycle support. Our technicians have an average of 25 years of experience and each one provides solutions and support from start to finish. Our turn-around times are faster than the rest, and we assist with corrective action, whether it is for one unit, one lot, or the recall of an entire product-line.
