Varian Smart Services uses the latest technology of the Internet of Things to achieve a close connection between the devices of the majority of users and Varian's big data analysis system as well as Varian's technical specialists and clinical experts, providing a new multi-dimensional service of people, machines and data. It is the first and only one in the radiotherapy industry to realize the forward-looking automatic warning function. At the same time, it can complete online troubleshooting, remote diagnosis and analysis, full tracking of repair problems and provide overall solutions, domestic technical specialist support, global technical linkage and other functions, so that users' equipment always runs in the best state. Through this digital transformation strategy and the Smart Services system, the health status of the equipment can be fully monitored, the technical pulse of each device can be grasped, health risks can be discovered, and risks can be solved remotely, so that each device can operate in an ideal state, the number of failures can be reduced, and downtime can be avoided. It ensures that Varian's medical linear accelerator maintains a very high availability rate, with an operating rate of more than 99%, which also makes this type of equipment have a very high market share in Taiwan. We are keen to provide better treatment for the majority of Taiwanese cancer patients and make due contributions to Varian.
Varian Medical Systems Haan GmbH, Manufacturing Site Kemnath
FDA 21 CFR 820 Quality System Regulations (cGMPs):
The design and manufacturing of Varian oncology system products comply with the requirements of the U.S. Federal Regulations governing Quality System Regulations (cGMPs).
International Organization for Standardization ISO 13485:
The design and manufacturing of Varian oncology system products comply with the requirements specified in the ISO 13485 quality standard. Varian Taiwan Co., Ltd. successfully passed the BSI certification audit of its Quality Management System in 2023 and obtained the ISO 13485:2016 certification.
ISO 14971:
The design, manufacturing, purchasing, distribution, installation, servicing, and post-market activities of Varian oncology system products comply with the requirements of the ISO 14971 standard for medical device risk management.
ISO 27001:
Varian Taiwan Co., Ltd. passed the BSI certification audit in 2023 and obtained the ISO 27001:2013 certification. In 2024, the certification was upgraded to ISO 27001:2022.
Service refers to equipment installation, maintenance, and technical support activities performed at customer sites to ensure equipment operates properly and meets performance requirements. Services may be classified as planned or unplanned.
Planned services are conducted according to preventive maintenance requirements or service technical bulletins, while unplanned services are initiated based on customer requests or unexpected equipment issues. Related activities shall follow applicable service procedures and guidelines.
All service activities must be documented in service records, such as cases or work orders. Services are generally performed onsite, although remote support may be provided when appropriate. If necessary, issues may be escalated for further investigation.
After service completion, equipment performance shall be verified to confirm compliance with product technical documentation before release for use.
Additional supporting documents may also be required according to document control procedures.
Any complaints identified during service activities shall be recorded and investigated according to complaint handling procedures. Patient health information shall be managed in compliance with Protected Health Information (PHI) requirements to ensure data security and regulatory compliance.
Relevant personnel shall also receive training on equipment defect awareness and risk management to support service quality and equipment safety.
Risks can be reduced through the implementation of one or more Risk Control Measures. These measures are intended to reduce the severity of harm, the probability of occurrence, or both, in order to ensure product and user safety.
Appropriate risk control measures shall be identified and implemented for the risks identified during risk analysis. Such measures may be achieved through safe design and manufacturing of the medical device, protective measures incorporated into the device or manufacturing process, as well as the provision of safety information, including warnings, precautions, contraindications in labels and instructions for use, and user training.
Risk control activities are considered complete only after all risk control measures have been implemented and verified and/or validated to ensure their effectiveness in reducing risks.
In addition, the Risk Management Team shall periodically review risk control activities to confirm that all identified hazardous situations have been adequately addressed and that all required activities have been completed. The review results shall be documented in the Risk Management Report for ongoing monitoring and management purposes.
Varian has established routine safety procedures for daily operation and maintenance, educational procedures, emergency procedures, and radiation hazard protection procedures to ensure the safety of system operators, patients, and service personnel.
To maintain the normal operation of information and communication network systems and ensure recovery within the shortest possible time in the event of natural disasters or human-caused disruptions, Varian Taiwan Co., Ltd. has established a Business Continuity Management Procedure in accordance with ISO 27001. This procedure assists system management units in developing business continuity plans and provides guiding principles for plan establishment, documentation, testing, revision, drills, recordkeeping, review, and evaluation, thereby ensuring the effectiveness of business continuity planning.
