Microscopy Solutions for Medical Device QA and QC
Medical devices, especially higher risk class II and III implantable devices (e.g., stents, dental implants, catheters) require precise inspection during quality assurance/quality control. Leica solutions help you identify, analyze, and document defects efficiently while ensuring compliance with regulatory requirements.
Please contact us for personal expert advice on our microscopy solutions for medical device quality assurance and quality control.
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How can I reliably detect micro-defects?
Using an optical microscope with appropriate resolution and illumination, users can accurately detect and measure defects, like cracks or other surface irregularities, in medical devices. Leica stereo microscopes provide a wide range of illumination options. FusionOptics enables users to see important sample details with an optimal 3D perspective.
How can I inspect irregularly shaped devices?
Having a microscope with a large depth of field and a flexible working distance is essential for inspecting irregularly shaped devices. With a working distance of up to 122 mm, the Ivesta 3 stereo microscope enables users to inspect in detail large or irregularly shaped samples.
How to avoid fatigue during visual inspection?
Work fatigue and strain is reduced by using ergonomically designed microscope workstations that promote user health and improve concentration leading to better quality of work. Ergonomic accessories for Leica stereo microscopes allow users to work in comfort, even over long periods of time.
How to visually inspect mixed material samples?
A medical device may consist of multiple materials (e.g., metals and plastic). Each material type needs a different kind of illumination during inspection. With the broad range of illumination options for Leica microscopes, users can efficiently observe edges and surface defects.
How do Leica microscopes help you improve quality assurance/quality control of medical devices?
Speed up quality control processes
The software available with Leica microscopes, e.g., LAS X for Industry and Enersight, offer users certain advantages for inspection of medical devices. The advanced modules of LAS X allow customized measurement templates, automated tasks, and customized reporting. Enersight is easy to use and offers measurement tools and features which help speed up inspection.
Inspect irregularly shaped devices
Leica stereo microscopes with the FusionOptics technology enable you to view and acquire images with a larger depth of field and higher resolution, helping you to see important details at a glance. This ability simplifies inspection of irregularly shaped devices like stents or catheters.
Increase comfort with ergonomics
There are a variety of ergonomic accessories for the M series stereo microscopes. Leica digital microscopes display sample images on a monitor. Users can view and analyze them while sitting in a comfortable position. You can improve performance with a well-designed work environment which is adaptable to various user needs.
Frequently asked questions Medical Device Quality Assurance and Quality Control Microscopy Solutions
Detection and analysis of burrs on medical-device components can be done in an efficient and reliable way with an optical microscope. The critical burr size determines the performance needed. Important factors are illumination and contrast methods, resolution, magnification, fast image capture, storage, and access, and practical measurement tools.
The appropriate magnification and resolution of an optical microscope for microscale-component inspection depends on the critical feature size. For features >15 µm, a magnification up to 60x and a resolution of 3 µm likely would be required. For those >2 µm, up to about 1,000x magnification and approaching 1 µm resolution. For those >0.6 µm, up to about 1,500x magnification and <1 µm resolution.
For inspection of medical devices, users can quickly and easily learn how to operate a Leica digital microscope with less training and supervision time, due to the consistent and intuitive user interface. Users spend less time adjusting the microscope and more time inspecting. Encoded optics make it easier to follow standard procedures, so users get reliable results. There is also the ability to efficiently document and discuss results with others via a digital image display.
To reduce user fatigue during inspection of medical devices, Leica microscopes can be optimized with key ergonomic and operation features. They are developed with user demands in mind, focusing on adaptability for various workflows needs, enhancing productivity and minimizing fatigue. Their ergonomic design ensures user comfort and reduces strain during long periods of inspection.
