Reliable image capture and analysis for your regulatory aﬀairs (RA) and QA/QC documentation: With microscope solutions from Leica Microsystems, you can rely on the results of visual inspection and documentation for medical devices.
Leica Microsystems oﬀers complete solutions for visual inspection which deliver reliable image data. Identify, analyze, validate, and document defects eﬃciently as a means to achieve compliance with regulations concerning your medical devices. Especially, when it comes to higher risk class II and III medical devices, such as stents, dental implants, catheters, and many other implantable ones, you can beneﬁt from these solutions.
Please contact us for personal expert advice on our microscopy solutions for medical device quality assurance and quality control.
Quality assurance and control (QA/QC) of your medical devices can require a lot of visual inspection with a microscope. You can encounter the following challenges:
- Difficulty to maintain consistent, efficient inspection, evaluation, and reporting of results across multiple operators due to the changing of ever-stricter regulations
- High effort needed to achieve reliable traceability of documentation required for highly regulated environments
- Paper-based documentation of visual inspection is time-consuming and effort intensive, because there are many steps, such as document hand-overs and physical storage and eventual digitization of documentation
- Spending many hours at a microscope can lead to strain due to an uncomfortable posture
These challenges can be overcome with digitally enhanced solutions and ergonomic accessories for microscopes offered by Leica Microsystems.
For medical device manufacturing, consistent inspection of defects, such as burrs, chips, and scratches is a necessity to meet the quality requirements. For compliance with standard procedures across multiple users, ensuring consistency is crucial. Additionally, it is important to rapidly adapt and implement changes to procedures.
- Leica stereo microscopes use high-quality optics and digital cameras enabling you visualize components in 2D and 3D with optimal contrast and resolution. They also provide distortion-free, sharp images and allow you go quickly from overview to details
- A more efficient inspection is possible with the FusionOptics technology which provides images with larger depth of field and maximum resolution compared to standard stereo microscopes