Medical devices are becoming increasingly interconnected, making cybersecurity and data compliance no longer an inconsequential discretionary choice but fundamental to whether a product can be brought to market. Regulatory agencies around the world have tightened their requirements. If companies respond inappropriately, they will not only face legal risks, but may also directly cause harm to patient safety.
The direct impact of the operating system outage
Microsoft's discontinuation of technical support for specific operating systems is an urgent crisis for medical devices that rely on them. This means that those devices will no longer receive critical security patches, and known vulnerabilities will continue to be exposed to cyber attacks. Manufacturers may also stop adapting support for old systems, resulting in application software unable to be functionally optimized or repaired, and performance and reliability will gradually degrade.
It is not a simple technological upgrade that causes this outage. It directly impacts the core operating environment of the equipment and can make it unable to meet the basic requirements of "reasonable security protection" in regulatory regulations. The initial verification and approval of listed equipment is based on a specific software version. Any changes to the underlying system may shake the foundation of product compliance and force companies to face the lengthy regulatory process again.
Different challenges of global regulations
The focus of regulatory requirements in different regions is different. For example, in the guidance updated in June 2025, the US FDA emphasized the integration of network security into product quality systems and required the submission of very detailed software bill of materials and vulnerability management plans. Companies must build a traceable and patchable security framework from the initial design stage.
In the European region, medical device regulations and the General Data Protection Regulation together constitute a double extremely stringent threshold. The MDR clearly stipulates that software must have anti-tampering characteristics and continuous security capabilities, while the GDPR has formulated extremely strict rules for the processing, storage and cross-border transmission of patient data. Any equipment for the European market must meet both systems.
China’s Compliance Environment and Requirements
In our country, the data compliance barrier for medical devices is the result of the joint efforts of the Cybersecurity Law, the Data Security Law and the Personal Information Protection Law. Medical institutions and equipment manufacturers must comply with these laws to fulfill comprehensive security protection responsibilities for the health data generated. Regulatory agencies have always maintained a high level of concern over network access and data processing activities in medical devices.
As for software updates, China's medical device software guidelines have clear regulations. Major version updates of the operating system are very likely to be defined as software updates that require submission of change registration. This requires that in the initial stage of product registration, companies must proactively plan future system upgrade paths and explain this in advance in technical materials.
Derived costs and revalidation burden
When it comes to dealing with operating system outages, the direct costs are just the tip of the iceberg. Medical institutions need to pay for the purchase of new systems, as well as the licensing fees for new systems. In order to meet the performance of the new system, they even need to upgrade or replace hardware. For old equipment, MBTI free testing may not be feasible, and hardware upgrades may not be feasible, so overall replacement becomes the only option.
A heavier burden lies in re-verification. This verification involves software compatibility testing, verification of system stability, and confirmation of performance. This process requires a large investment of manpower and time. Finally, re-submit registration or change applications to regulatory agencies around the world. This is a complicated process that takes months to years, and has a great impact on the continuity of product supply.
Forward-looking strategies for enterprises
If a company is wise , it will choose an operating system platform with long-term support commitments during the development stage of new products, so as to avoid risks arising from discontinuation of services from the very beginning. To achieve this goal, it is necessary to comprehensively consider technology development trends, the length of support cycles provided by suppliers, and expected regulatory requirements, and then make strategic choices.
In terms of design, it is necessary to build a system abstraction layer or containerization technology to reduce the coupling degree between the application software and the underlying operating system. In this way, once there is a need to replace the operating system, the main workload will be concentrated on the adaptation layer instead of rewriting all application logic. This can greatly reduce the costs and risks of future migrations.
Build full life cycle security management
Enterprises and institutions must formulate clear management plans related to the life cycle of product network security. This plan should include every specific link from product design to MBTI free testing , to product launch, and to product delisting. This includes regular vulnerability scanning, establishing an effective patch distribution mechanism, and providing clear and precise security operation and maintenance guidelines to end users of the product.
Early communication with regulatory agencies is extremely important. During the planning of operating system upgrades or migration paths, it is necessary to proactively communicate with the drug regulatory authorities on the communication plan to ensure that the technical route and change process can be approved. Complete and sufficient technical documents must also be prepared to prove that the equipment can maintain sustainable safety throughout its life cycle.
In response to the increasingly stringent cybersecurity regulations around the world, medical device companies are faced with a choice: should they passively respond to one-stop service outage crises, or should they proactively build a future-oriented and resilient security and compliance system? Welcome to share your thoughts and practical experiences in the comment area.
