Medical Device Evaluation Using the iEM Platform

The history of medical technology development is also the history of medical device miniaturization. With the efforts of manufacturers and researchers, the efficiency and accuracy of medical devices and precision tools are constantly improving. As medical devices require high standards of quality control and assurance, more accurate inspections are needed than ever before. Advanced electron microscopy and powerful sample preparation techniques allow better visualization of materials as well as observation of designed structures and layers. Creative Biostructure has years of experience in preparing and imaging a variety of materials based on our iEM Platform, a powerful integrated electron microscopy platform. We are able to evaluate the physical morphology and chemical properties of component surfaces for medical devices. We promise to deliver high-resolution images and fast measurements that can provide abundant and valuable information for evaluating the design, ergonomics, and safety of medical devices.

Quality Control and Assurance of Medical Devices

Manufacturers of medical devices must comply with all quality regulations, including all applicable ISO international quality standards, FDA, EMA, and other major body regulations. Quality assurance is achieved by meeting stringent inspection requirements at all steps of the process and conforming to quality management system standards. Most medical devices, such as medical needles, catheters, stents, pacemakers, and other such products, are used directly on the human body and have high-level requirements for safety, functionality, and effectiveness. Strict quality control and quality assurance are essential for medical devices due to microscopic scratches, burrs, and other defects that are very likely to damage the human body or put the patient"s life in danger.

Medical Device Evaluation at the iEM Platform

To achieve accurate and fast inspection and quality control of medical devices, iEM Platform is your right choice. Our typical techniques applied include scanning electron microscopy (SEM), transmission electron microscopy (TEM), confocal laser scanning microscopy (CLSM), atomic force microscopy (AFM). Among them, our SEM is equipped with a variety of functions. This instrument has very high magnification capabilities and can generate high-resolution images of surface structures. Combined with the Energy Dispersive X-Ray Spectroscopy System (EDX), SEM can be used to quantitatively analyze the elemental composition of materials. The image of polymer surfaces can be captured by SEM in low vacuum mode. In addition, the surface roughness parameters of medical devices can be detected by a specialized optical microscope.

We can help engineers and researchers,

• Morphology measurement and appearance inspection of medical devices.
• Surface analysis of medical devices.

- Analyze the elemental composition of the surface coating.

- Assess surface coating thickness and coverage.

- Evaluate surface roughness.

-Identify surface contaminants that affect adhesion.

• Material Characterization of medical devices.

-Characterize structures of novel materials.

-Cross-sectional analysis of multilayered materials.

• Analysis of defects and particles.

Thanks for your interest in our platform and solutions. We are always open to your questions and are happy to support you. contact us right now!