ZEISS Medical Industry Solutions​ Quality and Compliance​
ZEISS Medical Industry Solutions​

Quality and Compliance​

The safety and health of patients is the focus of medical technology. For this reason, the medical technology industry is one of the highly regulated industries. ZEISS understands the requirements and the resulting challenges that companies face. ​

Global companies need to fulfill the regulations of various authorities. In Europe, for example, these rules are defined in different EC directives (regulations and guidelines of the European Communities) and summarized in the MDR (Medical Device Regulation). In the USA, the Food and Drug Administration (FDA) is the relevant regulatory body. Separate guidelines are also maintained in China, Canada, South America, and elsewhere.

Overcome the hurdles of a regulation-driven industry

Quality Management Regulations​

21 CFR Part 820, ISO 13485​

ISO 13485 is a comprehensive management system that specifically addresses the production of medical devices. The FDA’s equivalent is 21 CFR Part 820, a quality system regulation for all finished products and devices intended for human use. Manufacturers need to ensure that these norms are met by their quality management processes and by all of their suppliers.

Data Handling Regulations​

GxP, 21 CFR Part 11​

The GxP (Good ‘X’ Practice) guidelines serve as a best practice handbook to help manufacturers comply with data handling regulations rules. ​

21 CFR Part 11 in the FDA’s Code of Federal Regulations defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. It requires companies in the medical industry to implement controls for software and systems that are used to process electronic data regulated by the FDA.

Key functionalities of ZEISS ZEN core GxP Toolkit​

ZEISS software solution for microscopy includes:​

  • 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

Learn more about regulation in medical industry​

  • Secure and Traceable Microscopy Workflows​

    Secure and Traceable Microscopy Workflows​

  • #measuringhero | Episode 71: FDA Title 21 Deep Dive​

    #measuringhero | Episode 71: FDA Title 21 Deep Dive​

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