Quality assurance for medical devices in different segments of medical technology industry

ZEISS MEDICAL INDUSTRY SOLUTIONS

Quality Assurance for R&D of Medical Devices

From R&D to the quality assurance of series production in medical device manufacturing

Overcome the hurdles of research, development, and QA lab environments within the regulated medical technology industry.

The processes and priorities involved in research and development are often different to those in production settings. Precision, speed, and innovative non-destructive testing (NDT) are crucial for mastering QA lab applications and powering progress in the medical field. Connected workflows and correlative microscopy are now taking things to a whole new level.

Manufacturers must implement appropriate quality assurance processes to handle the detailed steps involved in medical device research and development – as well as in QA lab environments. This will enable them to generate safe and effective solutions while demonstrating their ongoing compliance with medical regulations.

From CMMs to optical systems and from X-ray CT systems to microscopes - ZEISS has got you covered.
Click on the markers to see which applications the machine can solve in the R&D laboratory for medical technology products.

R&D in your quality lab

for all medical device applications

ZEISS PRISMO

- Surface analysis
- NDT & assembly control
- Dimensional analysis

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ZEISS O-INSPECT

- Surface analysis
- NDT & assembly control
- Dimensional analysis

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ZEISS ARAMIS

- Mechanical property analysis

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ZEISS ATOS 5

- Surface analysis
- NDT & assembly control
- Dimensional analysis

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ZEISS Smartzoom 5

- Internal defect/structural inspection
- Surface analysis
- Coating analysis

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ZEISS Axio Imager

- Material composition analysis
- Internal defect/structural inspection
- Surface analysis
- Coating analysis
- Technical cleanliness analysis

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ZEISS LSM 900

- Internal defect/structural inspection
- Surface analysis
- Coating analysis
- Technical cleanliness analysis

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ZEISS Sigma

- Material composition analysis
- Internal defect/structural inspection
- Surface analysis
- Coating analysis
- Technical cleanliness analysis
- NDT & assembly control

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ZEISS Versa

- Material composition analysis
- Internal defect/structural inspection
- Surface analysis
- Coating analysis
- NDT & assembly control
- Dimensional analysis
- Mechanical property analysis

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ZEISS METROTOM

- Internal defect/structural inspection
- Surface analysis
- Coating analysis
- NDT & assembly control
- Dimensional analysis

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Quality solutions

Material composition analysis

Analysis of structure, topography, and chemical composition

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

ZEISS Solutions for Materialography

Internal defect and structural inspection

Structural integrity of the part

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

Surface analysis

Non-contact handling of surfaces

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

ZEISS Surface Finish and Roughness Solutions

Coating analysis

Robust quality monitoring with AI support

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

Technical cleanliness analysis

Adaptable and correlative workflows

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

ZEISS Technical Cleanliness Solutions

Non-destructive testing and assembly control

Non-destructive fully assembled inspection

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

ZEISS X-Ray Solutions

External dimensional analysis

Precision handling of surfaces and tolerances

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

Internal dimensional analysis

Visualization, comparison, verification

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

ZEISS X-Ray Solutions

Mechanical property analysis

3D optical measurement

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

3D Testing

See how our customers have experienced ZEISS Medical Industry Solutions

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