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AAMI CR510 pdf free download

AAMI CR510 pdf free download.Appropriate use of public cloud computing for quality systems and medical devices.
4 Guidance on the six key recommendations
Recommendation I — Identify the intended function of the cloud computing resources within your product or service, including the impacted process areas.
Cloud services can be used to fulfill a variety of product goals. However, the specific design and function requirements may impact the choice of cloud service, the level of control or monitoring required, or ultimately could lead to the conclusion that certain products/processes are not well-suited to current cloud implementation.
In considering the cloud infrastructure, manufacturers should:
1. Begin with the overarching device requirements: There are likely to be significant differences in computing environment requirements for a medical device compared to a quality management system (QMS) or production control software tool. While a device computing environment often has the potential to directly affect device outputs and therefore patient risk, QMS and production control software are typically bolstered by process or other controls (e.g., device inspections, output review, etc.) which further reduce the chances that a process failure turns into a device defect.
2. Consider how the device requirements may differ in a cloud implementation by comparing the affected process areas in personal computers, server-based computing in data centers, mobile devices, Internet of Things, etc. and assessing changes to the risk profile.
For example, changes in processors, architecture or data flow may impact the validity of results.
3. Consider the available cloud service models (platform as a service (PaaS), infrastructure as a service (laaS), software as a service (SAAS), or hybrid) and infrastructure and their risks to the device based on application needs. For example, some devices may require uptime approaching 100 % or real-time results whereas others may be tolerant of delays due to clinical indication or if the cloud function is supporting outputs such as trending or population insights.
Recommendation 5 — Establish a plan in case an update adversely affects your software that includes.
1. a temporary fallback (if necessary) to step back from the change in the public cloud platform;
2. a process to return the software to a validated state while accommodating the change in the public cloud platform; and
3. a post-incident analysis to improve the future resiliency of the software.
When establishing a temporary fallback plan, the manufacturer should consider mitigations for cloud modifications that have high impact on their device. These might include contingencies such as temporary failover to a known, validated instance maintained by the manufacturer for emergency use. This strategy could be coupled with a robust Service Level Agreement (SLA) that ensures the cloud provider is committed to rapid rollback, including application and data availability, when required.
Alternatively, working with the cloud provider, it may be possible to identify the standard rollout sequence for updates, such that upon detection of an issue, instances can be activated in a “lagging instance” where the offending change has not yet been implemented.
The prospect of frequent, unobserved, and incremental (FUI) changes is core to both the benefits and the  risk profile of cloud-based devices. Several considerations may help manufacturers navigate this update paradigm to the regulated software space. AAMI CR510  pdf download.

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