Soluciones ZEISS para la industria médica

Aseguramiento de calidad para los más altos estándares médicos

Soluciones de metrología para componentes médicos

Con sus altos requisitos regulatorios y muchos productos que tienen un impacto directo en la calidad de vida de las personas, la industria de la tecnología médica depende de sistemas confiables para el aseguramiento de la calidad.

ZEISS comprende las normativas, sus requisitos y los retos a los que se enfrentan los fabricantes y sus departamentos de calidad. Nuestro portafolío inteligente ofrece soluciones de hardware y software a medida que respaldan los estándares de la industria y funcionan como un sistema coherente para brindar a los fabricantes la certeza que necesitan para obtener la productividad que desean.

Eliminando todos los obstáculos Con el portafolio de soluciones ZEISS

Prueba de calidad

Cumplimiento de informes médicos FDA, MDR, etc

Regulación de manejo de datos FDA 21 CFR Part 11

Regulación para el aseguramiento de calidad ISO 13485:2016, FDA 21 CFR Part 820

quality assurance software showing capability and compliance for record keeping in medical industry

ZEISS ofrece un portafolio completo de hardware que incluye máquinas de medición de coordenadas ópticas y táctiles (CMM), escáneres 3D, microscopios, así como soluciones de Rayos X y CT (Tomografía computarizada). Nuestros clientes se benefician de una resolución, precisión, velocidad de medición y potentes funciones de automatización líderes en su clase.

ZEISS Software incluye: 

  • Cumplimiento de los requisitos de DIN EN ISO 13485 y FDA 21 CFR Part 11
  • Gestión segura de usuarios
  • Integración de seguimiento de auditoría y gestión de versiones
  • Creación automatizada de certificados y certificados de prueba del fabricante.
  • Validación continua
  • Control de versiones de documentos y protección contra modificaciones
  • Conceptos de autorización detallados que incluyen firmas electrónicas
  • Recuperación de desastres
  • Indicadores de desempeño en línea de toda la empresa e indicadores clave de desempeño

Soluciones de calidad para todo tipo de implantes

Diferentes implantes, mismos procesos de fabricación

Si bien existen muchos implantes y filosofías de fijación diferentes, y las soluciones son diversas, los procesos de fabricación de los componentes individuales siguen siendo similares. Por sus propiedades materiales, los implantes ortopédicos se pueden clasificar según los procesos de fabricación. Esto nos permite ofrecer soluciones de calidad a medida en los segmentos individuales, lo que conduce a un aumento de la productividad en tu proceso.

Implantes Dentales

Debido a la forma de los implantes dentales, la medición de la rosca de toda la superficie del componente es más desafiante.

Los implantes dentales se fabrican dentro de un proceso de trabajo de metales.

Image of a dental implant in jaw. Challenge; Metal working of small components  with tight tolerances.

Implantes de hombro

Un implante de hombro consta de una glenosfera, un implante glenoideo, tornillos periféricos y un vástago humeral. La medición del perfil de forma libre del vástago estrecho es el mayor desafío metrológico para este tipo de implante.

Mientras que el implante glenoideo está hecho de plástico, los demás componentes se fabrican con metal.

Shoulder implant. Challenge; Metal, Plastic Large variance in component size capabilities required

Implantes de columna

La inspección completa de barras sin referencias datum es la mayor dificultad para medir implantes espinales. Para estos implantes, los discos intervertebrales se fijan mediante varillas vertebrales y tornillos pediculares monoaxiales.

Todos los componentes de los implantes de columna están hechos de metal.

Spinal Implant Challenge; Metal Both rods and screws require the highest accuracy when measuring their  axis.

Implantes de cadera

Es la baja tolerancia de múltiples piezas hechas de varios materiales lo que dificulta la medición de los implantes de cadera. Estos implantes se componen de una copa acetabular, un revestimiento de polietileno, una cabeza femoral y un vástago femoral.

El revestimiento de polietileno está hecho de plástico, mientras que la copa acetabular y el vástago femoral son componentes del procesamiento del metal. La cabeza femoral se compone de cerámica y metal.

Hip implant in hip and femur. Challenge; Metal, Plastic, and Ceramic. Different material processes all with small tolerances

Knee Implants

When measuring knee implants accurately, it is important to ensure that no white marks are left behind. A knee implant consists of metallic and plastic components. 

The femoral implant as well as the tibial tray are manufactured within a metal working process. The tibial insert is produced within a plastic manufacturing process.

Knee implant Challenge; Metal and plastic processing.  Need for an interference fit between tibial plate and insert with an aligned fit with femoral implant

Bone Implants

Bone screws and bone plates are used for implants in the field of trauma & extremities. The biggest metrology challenge of bone plates are multi-axis measurements of shallow bores on a freeform surface.

Bone implants are made of metal.

Bone plate implant in leg. Challenge; Metal working a plate with contouring surface and locking splines in different axis

Metal Working Process

Orthopedic implants must function flawlessly even under the demanding physiological conditions in the human body. This makes it a central requirement for manufacturers to gain a deep understanding of orthopedic materials - metallic compounds, ceramic, and polymers - and the resulting organic reaction. One of the most important steps in the metal working process is assessing the raw materials properties to ensure the performance of the product. Other important challenges are the geometric dimensioning, technical cleanliness during the manufacturing process and efficiency gains through minimizing waste.

From Raw Material to Finished Parts

Quality Gates and Solutions

Stock cylindrical metal. Colored to show grain size and direction of metal domains with an image from a microscope to the top left of the cylinder.

Metallography

Analysis of Raw Material

The challenge

  • Assure constant quality of raw material from a micro to nano scale with respect to e.g. porosity, voids, cracks, fissures and grain size

Your benefit with ZEISS

  • Determine the root cause of failure to improve overall reliability

Software Solutions

Light Microscopy Systems

Electron Microscopy Systems

Initial Forging of the hipstem from stock material. Voids in blue to show possible defects in forging process. Magnified voids above the stem.

Quality of Raw parts

Inspection of Primary Shape

The challenge

  • Ensuring that the components are produced in good shape and without fissures voids, cracks or critical inclusions

Your benefit with ZEISS

  • Fast inspection of produced components to prevent cost-intensive failures later in the manufacturing process

Software Solutions

Scanning Solutions

CT- and X-Ray Systems

Forged stem shown to show flashing form the forging process. Would be as received part from the supplier.

Incoming Inspection

Efficient Verification of Supplied Parts

The challenge

  • Ensuring supplied parts are within the margins for machining and processing
  • Fast inspection cycle times to reduce probability of bottlenecking

Your benefit with ZEISS

  • Programable inspection plans, which are executable in CNC
  • Optimize your machining time and sort out waste parts before they turn into products

Software Solutions

Scanning Solutions

Coordinate Measuring Machines

Stem further processed. Image above shows microscope image of debris on filter. From cleaning processed part.

In Process Control

Observation of Processing Quality

The challenge

  • Detect and classify particulate contamination to fulfill the quality standards in the medical industry
  • Inspections in process steps are necessary to control the processing and avoiding unnecessary scrap.

Your benefit with ZEISS

  • Combine particle detection and classification in a Technical Cleanliness workflow that not only finds particles, but also helps classify them by contamination or wear origin
  • Avoid further processing of scrap parts

Software Solutions

Light Microscopy Systems

Electron Microscopy Systems

Scanning Solutions

Mostly processed stem. Lines describing nominal lengths. Image above to show stylus making contact with the part to measure said dimensions.

Geometric Dimensioning

Final Dimensioning

The challenge

  • Critical factors for quality assurance are cycle time and the reliability of results
  • Tight profile tolerance on polished surfaces are a challenge for traditional inspection methods

Your benefit with ZEISS

  • Increase usable acceptance range by decreasing measurement uncertainty
  • Reduce operator influence and need for manual inspection by using CNC inspection

Software Solutions

Scanning Solutions

Coordinate Measuring Machines

Completed hip stem. Showing highlighted witness marks. A topography image above the stem shows morphological characteristic of the finished surface.

Surface Analysis

Final Visual Inspection

The challenge

  • Finished products have to be checked to guarantee the correct layer thickness and a flawless surface quality
  • Polishing results in a mirror-like finish that poses challenges for optical inspection

Your benefit with ZEISS

  • Fast contactless evaluation of roughness
  • Reproducable and fast results in final inspection

Software Solutions

Light Microscopy Systems

Surface Inspection & Characterization

Plastic Manufacturing Process

Due to the manufacturing process, plastic implants can be produced very efficiently as large batches, but also individually. Sometimes these are individual parts that have been specifically manufactured for the patient. This is because the great advantage of plastics in medicine is that they can be shaped in a variety of ways and can therefore be adapted well to the respective needs of the patient. Especially ultra high molecular weight polyethylene (UHMWPE) has seen great successes in medical implant applications due to its high abrasion resistance, high toughness, and great biochemical inertness. The precise manufacture of the sometimes very small parts with complex geometries is now technologically possible thanks to ultra-modern machines and systems.

From Raw Material to Machined Parts

Quality Gates and Solutions

Initial geometric dimensions of stock material and shape.

Incoming Inspection

Efficient Verification of Stock

The challenge

  • Ensuring supplied parts are within the margins for machining and processing
  • Fast inspection cycle times to reduce probability of bottlenecking

Your benefit with ZEISS

  • Programable inspection plans, which are executable in CNC
  • Optimize your machining time and sort out waste parts before they turn into products

Software Solutions

Scanning Solutions

Coordinate Measuring Machines

Processed plastic part with highlighted dimensions. Image above shows voids on the interior of the part.

Geometric Dimensioning

Final Dimensioning

The challenge

  • Critical factors for quality assurance are cycle time and the reliability of results
  • Tight profile tolerance on polished surfaces are a challenge for traditional inspection methods

Your benefit with ZEISS

  • Increase usable acceptance range by decreasing measurement uncertainty
  • Reduce operator influence and need for manual inspection by using CNC inspection

Software Solutions

Scanning Solutions

CT- and X-Ray Systems

Coordinate Measuring Machines

Get more Insights into Quality Assurance for Medical Components

#measuringhero Vlog

Your Global Partner

Shape the Future of the Medical Industry together with ZEISS

Medical parts are rarely produced in a single location. Yet measurement and inspection issues can pop up in any country and at any supplier. Our global network of application engineers and service are here to help solve your quality assurance challenges so you can keep traceability and quality at a consistently high level.

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ZEISS Medical Industry Solutions Quality Assurance for the highest medical standards