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 ZEISS ZEN core GxP Toolkit

Learn more about regulation in medical industry

Secure and Traceable Microscopy Workflows
#measuringhero | Episode 71: FDA Title 21 Deep Dive

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Quality and Compliance​