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Metrology Solutions for Medical Components
With its high regulatory requirements and many products that have a direct impact on the quality of peoples’ lives, the medical technology industry depends on reliable quality assurance systems.
ZEISS understands the regulations, their requirements and the challenges faced by manufacturers and their quality departments. Our connected quality intelligence portfolio offers tailored hardware and software solutions that support industry standards and work as a coherent system to give the manufacturers the certainty they need to gain the productivity they desire.
Clearing all Hurdles With the ZEISS Connected Portfolio
Proof of Quality
Guideline Compliance FDA, MDR, etc
Data Handling Regulation FDA 21 CFR Part 11
Quality Management Regulation ISO 13485:2016, FDA 21 CFR Part 820

ZEISS offers a comprehensive and connected portfolio of hardware solutions that includes tactile and optical coordinate measuring machines (CMMs), 3D scanners, microscopes as well as CT and X-ray solutions. Our customers benefit from class-leading resolution, accuracy, measurement speed and powerful automation functions.
ZEISS Software Solutions include:
- Compliance with the requirements of DIN EN ISO 13485 and FDA 21 CFR Part 11
- Secure user management
- Integration of audit trail and release management
- Automated creation of certificates and manufacturer test certificates
- Continuous validation
- Versioning of documents and protection from modification
- Detailed authorization concepts including electronic signatures
- Disaster recovery
- Company-wide online performance indicators and key performance indicators
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.
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.
Get more Insights into Quality Assurance for Medical Components
#measuringhero VlogYour Global Partner
Shape the Future of the Medical Industry together with ZEISSMedical 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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Analyze.
Identification of specific quality demands and subsequent needs.

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ZEISS team customizes perfect fitting solution.
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