ZEISS Medical Industry Solutions

Quality Assurance for the Highest Medical Standards

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

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

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

Quality Solutions for Different Types of Medical Products

The requirements for quality assurance of medical products are high. Different application purposes and manufacturing processes require different inspection steps and methods. Learn more about the quality gates of the different medical segments:  


Discover the quality gates and solutions for the production process of medical implants.

Medical Plastics

Learn more about quality assurance in tool manufacturing and precision injection molding of medical plastic products. 

Get more Insights into Quality Assurance for Medical Components

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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.



Contact us to book a consultation.


Identification of specific quality demands and subsequent needs.


ZEISS team customizes perfect fitting solutions.

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ZEISS Medical Industry Solutions Quality Assurance for the highest medical standards

In medical technology, particularly high demands are placed on quality. Find out how ZEISS ensures quality assurance processes in medical technology.

See how other customers have experienced ZEISS Medical Industry Solutions