PLM with effective document management ensures compliance
Olympus Surgical Technologies Europe ensures a regulatory-compliant development process for medical technology products with CIM Database
- Products for minimally invasive applications
- 1,800 employees at four locations (2024)
From diagnostics and therapeutics to reprocessing and the connected operating room: Olympus Surgical Technologies Europe offers a full range of minimally invasive applications with products in the fields of endoscopy, bipolar high-frequency surgery, operating room system integration, and instrument reprocessing. The group combines core competencies such as research and development, production and service, as well as sales and training. Since 2009, 600 employees at four locations of Olympus Surgical Technologies Europe have been using CIM Database as their PLM system. The company ensures an efficient and compliant development process, primarily through effective document management.
- Compliance management – Ensuring a compliant development process, including comprehensive project documentation
- Consideration of globally diverse markets and regulatory approval requirements
- Centralized platform for CAD data management and item management
- Powerful integrated document management, including digital signatures
- Easy adaptability of the system
- CIM Database as a PLM platform for an efficient and compliant development process
- Efficient representation of engineering change processes through workflow design by linking item and document structures
- Comprehensive document management for the standardized administration of all audit-relevant documents, including Office integration
- Integrated solution for digital signatures
- CAD data and item management
- Cost savings through significant reduction of time spent on documentation
- Support for meeting country-specific requirements for approval processes and audits
- Acceleration of approval processes through instant availability of electronic documents
- Compliance with the strictest documentation and verification requirements under the regulations of the U.S. Food and Drug Administration (FDA) and the European Medical Device Directive (MDD)
- Minimization of administrative development efforts thanks to automated processes
- Digital signature solution can be used not only for documents but also for data objects such as requirements or product structures
“The linking of article and document structures brings enormous time advantages in the change process.”
Ronny Hübl
Head of Project Management Office
Olympus Surgical Technologies Europe
