Quality Assurance in R&D of Medical Products

ZEISS hardware and software for quality assurance in R&D

Rigorous quality control throughout the R&D process is essential to ensure that medical products meet the highest standards. ZEISS offers tailored, seamlessly integrated hardware and software solutions for data analysis and reporting, helping manufacturers achieve the desired excellence.

To meet the regulatory demands of medical technology authorities, manufacturers must exceed standard quality assurance requirements. They not only need to establish industry-specific workflows correctly but also document and validate consistent adherence to them. Quality assurance hardware and software must work seamlessly together, providing the necessary functionality while integrating smoothly into subsequent steps of series production.

Material composition analysis
A fundamental step in ensuring the reliability of manufacturing materials is the analysis of their composition. Key challenges include characterizing the chemical composition of bulk materials while focusing on factors like porosity, cracks, and inclusions. Advanced techniques such as light microscopy (LM) and scanning electron microscopy (SEM) are employed to capture particle sizes and reveal detailed compositions. Automated evaluation systems using ZEISS ZEN core templates facilitate the early detection of material quality fluctuations, enhancing reliability and product performance.

Internal defect and structural inspection
Achieving defect-free components is crucial for meeting static and fatigue performance requirements in medical technology. Defects such as pores and cracks above a critical size can compromise structural integrity, while material inclusions may lead to localized brittleness. Reliable inspection methods are essential to detect these flaws early. Additionally, continuous process stability monitoring is key to maintaining consistent part quality.

Light microscopes identify surface failures, while electron microscopes provide high-resolution imaging of fracture characteristics. X-ray computed tomography (CT) and X-ray microscopy enable non-destructive scans to detect internal defects and cracks.

Quality assurance solutions for the research and development of medical devices

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From technical cleanliness to mechanical properties and material composition, each stage of the R&D process poses its own challenges. ZEISS has got you covered with innovative technologies that ensure quality and compliance every step of the way. Discover how our solutions help overcome hurdles and power progress in the medical field.

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Characterization of surfaces
Surface analysis in medical technology presents unique challenges, especially for complex inner surfaces of porous or trabecular structures. Assessing active coatings like hydroxyapatite requires precise evaluation of thickness, structure, and bonding to the substrate. Additionally, understanding surface roughness and the effects of various treatments is essential to ensure optimal functionality and durability.

LM and SEM deliver full characterization of surface coatings. Non-contact inspection methods like CT and X-ray microscopy are crucial for characterizing structural coatings in hard-to-reach areas without destruction of the sample. CMMs allow for accurate measurements of form, size, and position, critical for quality assurance.

Coating analysis
Inspecting complex surface coatings is time-consuming, and evaluations are challenging. However, it is an important part of quality monitoring, ensuring compliance with international standards such as DIN ISO and ASTM. X-ray microscopes and combined microscopy techniques deliver repeatable and reproducible results. High accuracy is achieved through advanced AI-based software analysis.

Non-contact measurement of sensitive surfaces

Dimensional analysis
Maintaining precision in both external and internal features of medical devices is critical for quality and compliance. Externally, the focus lies on accurately measuring geometrical product specifications (GPS) of intricate 3D surfaces, while internally, the challenge is to capture high-resolution images of critical structures.

Advanced solutions include optical scanners for delicate components, multisensor CMMs for high-precision scanning, X-ray CT technology for simultaneous internal and external measurement, and X-ray microscopy visualizing submicron internal structures and delivering comprehensive, non-destructive insights.

Technical cleanliness analysis
With stringent standards like VDI 2083 regulating particle contamination analysis, technical cleanliness is increasingly important during the R&D phase. ZEISS offers a technical cleanliness solution that enhances productivity and compliance, integrating LM and SEM data for comprehensive analysis.

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Mechanical property analysis of a hip implant

Mechanical property analysis
To ensure medical devices withstand loads as intended and function effectively over time, their mechanical properties must be analyzed. Traditional measuring strategies use strain gauges or displacement transducers which often results in limited data and these approaches are even not suitable for delicate and soft biomaterials like tissue and tendons. Additionally, the interpretation of test results is complex, as human body kinematics introduce intricate motion patterns.

ZEISS offers an optical 3D measurement system that replaces strain gauges or displacement transducers and delivers precise 3D coordinates for statically or dynamically loaded samples and components. Based on that, ZEISS ARAMIS allows the determination of 3D displacements, velocities, accelerations and the analysis of movements according to the six degrees of freedom (6 DoF) approach.

Software solutions for R&D processes
ZEISS CONNECTED QUALITY and ZEISS PiWeb support data processing and analytics, while ZEISS ZEN core offers a correlative workflow, data storage, automated AI functionality, and GxP toolkit for microscopes.

AI-assisted inspection of implant coatings

Thanks to AI-assisted solutions from ZEISS, medical technology group Smith+Nephew is now ten times more productive in the inspection of implant coatings. Our technology has not only drastically reduced inspection times but also prepares them for future standards.

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Accelerating Medical Innovation with Uncompromising Quality

More about quality assurance in R&D

AI-assisted inspection of implant coatings