ZEISS Medical Industry Solutions

Quality Assurance for the Highest Medical Standards

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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

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:

Orthopedics

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

Discover the quality gates

Medical Plastics

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

Discover the quality gates

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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.