For Medical Device Testing, Every Variable is Important
The analytical evaluation threshold (AET), an important part of the extractables and leachables testing in these studies, needs to be calculated for each instrumental technique.
Failure Analysis of Medical Device Electronics
Medical device and diagnostics companies have taken great strides in the development of newer technologies to provide better patient assessment and treatments. Devices of the future will require smaller features, lighter materials, and improved stability. Not only is it important to assess the materials and chemistry in medical devices, but it is also equally as important to assess medical device electronics to ensure safety and reliability. From hearing aids to heart pacemakers to catheters and more, advanced electronics can be seen in many of today’s medical devices.
How EAG Failure Analysis Can Help:
Every day the medical industry lunges forward with more advanced instruments and higher quality consumer products. This new level of sophistication also translates into more complex R&D processes. As the manufacturing process gets more complex, there are many more opportunities for things to go awry. Identifying, diagnosing, and remedying failures becomes dramatically more challenging. Our experienced engineers and scientists possess a comprehensive array of advanced tools and techniques that can perform failure analysis on a large range of electronic devices.
Examples of Techniques We Can Use:
- 2D X-ray imaging/3D CT Scanning: To quickly screen for gross anomalies non-destructively. This would be a great non-invasive way to validate construction/assembly steps.
- Iterative stress testing: EAG can assist with simulation testing to characterize how well the product would perform under adverse conditions such as environmental stress or electrical stress
- Scanning acoustic microscopy: To characterize internal construction and to identify internal voiding or delamination non-destructively.
- Material analysis: Elemental analysis can be vital to understanding if contamination played a role in a failure.
- System-level testing: EAG can assist with system level testing to help identify a specific failing device. This can involve design/schematic review, bench testing and microprobing.
- Electrical characterization: Once the failure is isolated down at the system level, EAG can then perform electrical characterization at the subsystem or device level to further understand the root cause.
- Fault isolation: EAG can perform fault isolation techniques like thermal imaging both at the system level and at the device level to characterize damage or inherent defects.
- Warpage analysis: Topography deformation is a good way to characterize coefficient of thermal expansion mismatches throughout a PCBA, a specific device or even an assembled module.
- Deconstruction: A comprehensive deconstruction of a product would be a good way to validate the physical attributes of a build
- Physical analysis: After a specific location on the failing device of interest is identified, EAG can assist with physical analysis to determine the root cause.
Eurofins EAG Laboratories offers the most diverse and comprehensive suite of testing and engineering support available for medical devices. With failure analysis services that range from non-destructive examination to physical analysis for root cause identification, our failure analysis team has the engineering expertise to help solve problems at any phase of the product cycle. EAG understands the stringent regulations, requirements and expectations of medical devices and are therefore the perfect partners to assist with advancements in the medical device industry.
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