Quality Assurance for R&D of Medical Devices

Challenges:

• Characterization and chemical composition of bulk stock material and raw powder
  
• Material quality assessment: porosity, cracks, grain structure, critical inclusions

Your benefit with ZEISS:

• Light microscopy: capture large powder particle or raw material size
• Scanning electron microscopy: Automated EDX measurements in ZEISS SmartPI software reveal chemical composition of material
  
• Segmentation and auto-evaluation of porosity, crack, and inclusion images within predefined ZEISS ZEN core job template
• Consistent material feedstock quality with early detection of fluctuations
• Assess material recycling/reuse strategy
  
  

Challenges:

• Eliminating defects, like pores and cracks above a critical size to meet static or fatigue performance requirements
• Material inclusions can increase localized part brittleness

Your benefit with ZEISS:

• Light microscopy: for visual inspection to identify surface failures or fracture surface imaging to identify failure mode and potential initiation point
• Scanning electron microscopy: for high-resolution imaging of fracture features, failure propagation and elemental analysis to confirm correct material composition, also performed using SEM with EDS to identify the root cause of defect
• X-Ray CT and X-Ray microscopy: non-destructive volumetric part scans to identify internal defects and cracks
  
  

Challenges:

• Non-contact inspection of structural coatings on complex hidden inner surfaces (porous/trabecular structures)
• Characterizing active surface coating (hydroxyapatite) and identifying thickness/structure of protective surface coatings (anti-corrosion treatments)

Your benefit with ZEISS:

• LM and SEM solutions: meet external surface requirements, full characterization of surface coatings, layers, or treatments
  
• CT and X-Ray microscopy: Handle complex hidden internal surfaces
• CMM: measure form, size, and position with ZEISS DotScan and tactile roughness measurement with ZEISS ROTOS

Challenges:

• Need highest accuracy to monitor quality of surface coated structures in line with international standards (DIN ISO, ASTM)
• Complex structures require advanced AI-based software analysis to ensure part quality and productivity

Your benefit with ZEISS:

• Combined microscopy (LM and SEM): ZEISS ZEN core software suite for multi-modal microscopy, robust analysis methods deliver repeatable and reproducible results
  
• X-Ray microscopy: non-destructive imaging at submicron resolution
• ZEISS ZEN core AI platform with ZEISS arivis Cloud for AI image analysis based on deep learning
  

Challenges:

• Particle contamination detection that meets strict standards e.g. VDI 2083 page 21
  
• High-quality particle itemization and classification

Your benefit with ZEISS:

• ZEISS Technical Cleanliness Solutions: adaptable workflow with ZEISS ZEN core module with analysis, reporting, and archiving in just a few clicks
• Combining light microscopy and scanning electron microscopy data in correlative solution for more productivity and simpler technical cleanliness process
  
  

Challenges:

• Drug delivery devices require a stringent quality assurance process for assembly control purposes
• Non-destructive testing (NDT) crucial to assess interaction of internal components while keeping medical device intact

Your benefit with ZEISS:

• X-Ray microscopy: visualize and evaluate submicron internal structures incl. active ingredients
• X-Ray computed tomography: for full non-destructive characterization of internal structures and components
• Full device characterization enables evaluation of porosity, inclusions, geometry, and assembled functionality
• Swift AI assessment of non-conforming areas plus clear full 3D visualization
  

Challenges:

• Measurement and verification of all geometrical product specifications (GPS) of complex 3D surface structures
• Non-contact measurement of precision mirror surfaces and non-touch flexible plastic components
• Meeting multi-load requirements to boost productivity

Your benefit with ZEISS:

• Optical scanners: easy scanning of fragile/flexible components, Manual and automatic systems auto-inspect part batches without being affected by complex geometries
• (Multisensor) CMM: flexible multisensor systems, micron-range active scanning and pinpointing of critical parts of geometry prone to quality issues
• X-Ray CT: simultaneous measurement of interior and exterior features
  

Challenges:

• Quality control of structurally important internal features with high-resolution images
• Non-destructive visualization of complex internal structures

Your benefit with ZEISS:

• X-Ray microscopy: non-destructive imaging at submicron resolution
• X-Ray CT: perform dimensional inspection and digitize complex parts including internal geometries
  
  

Challenges:

• Hard to attach strain gages/displacement transducers to small medical devices: incomplete data, impaired accuracy, not suitable for delicate and soft biomaterials like tissue and tendons
• Difficult to interpret results due to complex motion patterns within human body kinematics
• Improperly fixed implant may move, impairing test results

Your benefit with ZEISS:

• ZEISS ARAMIS 3D Measurement System: analyze article under test for motion and deformation
• Non-contact optical measurement: no biomechanical test article interference, no strain gage slip, no improper sensor fixtures
• Quick setup means test bench components can also be integrated into measurement
• Holistic measurement database suitable for intuitive visual interpretation