Safety, Efficacy, and Speed to Market are the goals for medical device product development. Optical inspection is a critical component of medical device feasibility and fatigue testing, providing test method verification and early test results. Medical Device Testing Services utilizes a variety of inspection capabilities to improve the quality of our services and to better ensure acceptance of the test data by regulatory organizations such as FDA and CE. Applications include:
Depending on your product pipeline status, inspection documentation can be included in future test protocols, submitted to FDA consultants for test review, or submitted with interim-test data for early FDA or CE submissions.
High Speed Camera: The IDT camera is the pinnacle of high speed imaging. MDT uses video to verify dynamic test fixture and sample motions. Video is analyzed using ProAnalyst software to provide high resolution and repeatable motion analysis.
Digital Microscope: The Nikon digital zoom microscope is used to inspect samples (up to 100x) pre-test, during the test, and post-test as well as digitally archive sample images.
Video Endoscope: The Olympus high resolution video endoscope with articulated end is utilized by MDT to inspect samples deployed in mock vessles or on complex fixtures pre-test, during the test, and post-test without removing the samples from the test fixture;as well as digitally archive sample images.
Scanning Electron Microscope (SEM): MDT has an Aspex Model 3025 SEM system with Automated Feature Analysis (AFA) Software and Energy Dispersive X-ray Spectroscopy (EDS) capabilities. Scanning electron microscopy is performed at high magnifications, generates high-resolution images and precisely measures very small features and objects.
ProAnalyst Image Analysis: The industry standard for automatically measuring moving objects and still objects with video and digitial images. Coupled with one of the imaging systems above, this powerful tool can be used to analyze test fixtures, test movements, sample movement, and sample integrity.