--- title: Medical Device Manufacturing - CEMS Wireless Monitoring description: Ensure FDA compliance in pharmaceutical and medical device manufacturing with Setra’s wireless temperature monitoring. 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Unused for Credit](https://www.setra.com/product-return) [Contact Us](https://www.setra.com/help-center) # **Medical Device Manufacturing** ## **Wireless Monitoring Solutions** Maintaining stringent environmental conditions is crucial in pharmaceutical and medical device manufacturing to ensure product safety and compliance with FDA regulations. Setra's wireless temperature monitoring systems provide real-time data logging and automated alerts, ensuring that your products are stored under optimal conditions and comply with regulatory standards. Our solutions are designed to eliminate manual temperature checks, reducing the risk of human error and freeing up valuable resources. For instance, in the production of temperature-sensitive medical devices like insulin pumps, precise environmental control is essential to prevent defects and ensure product integrity. Similarly, pharmaceuticals such as vaccines and biologics must be stored within specific temperature ranges to maintain their effectiveness. By implementing Setra’s systems, manufacturers can focus on innovation and production efficiency while ensuring that storage conditions are continuously monitored and maintained. ![(960x540)Clean Room Manufacturing](https://www.setra.com/hs-fs/hubfs/(960x540)Clean%20Room%20Manufacturing.jpg?width=486&height=273&name=(960x540)Clean%20Room%20Manufacturing.jpg)   ### **Key Features of Setra’s Medical Device Manufacturing Solutions** - **Drive Compliance:** Ensure the effectiveness of critical control procedures and protocols by eliminating human error and incorrect data, with secure recording on a fully auditable platform. - **Centralized Reporting:** Access and consolidate data from multiple departments and sites into a central, multi-user reporting platform for management on the move. - **Budget Conscious:** Maximize your budget by investing in automated monitoring, reducing the need to replenish valuable stock that may otherwise spoil due to temperature fluctuations. - **Increased Efficiency & Labor Optimization:** Optimize key resources and increase productivity by automating routine temperature recording tasks. - **Reduce Waste:** Automated 24/7 monitoring allows proactive management of your temperature-controlled assets, mitigating product loss. - **UKAS & ISO 17025 Accredited Calibration:** Setra has ISO 17025 & UKAS accredited calibration laboratories, and we can bring these services to you with our onsite engineers. **Featured Products** --- [![cems-diligence-Screen-mockup_500px](https://www.setra.com/hs-fs/hubfs/cems-diligence-Screen-mockup_500px.png?width=314&height=236&name=cems-diligence-Screen-mockup_500px.png)](https://www.setra.com/products/environmental-monitoring/model-flex-environmental-monitor-0) **Setra CEMS™ Diligence** Wireless Monitoring Solution [**View Product**](https://www.setra.com/cems/cems-diligence) [![cems+hardware-1](https://www.setra.com/hs-fs/hubfs/cems%2Bhardware-1.png?width=291&height=236&name=cems%2Bhardware-1.png)](https://www.setra.com/cems) **Setra CEMS™ Connect** Multi-Parameter Monitoring Solution [**View Product**](https://www.setra.com/cems/cems-connect) **Blogs & Resources** --- ![CEMS mobile app](https://www.setra.com/hs-fs/hubfs/CEMS%20mobile%20app.webp?width=238&height=223&name=CEMS%20mobile%20app.webp)   **Exploring the New Setra CEMS Mobile App ** [**View Now**](https://www.setra.com/blog/setra-cems-mobile-app) ![environment monitoring](https://www.setra.com/hs-fs/hubfs/environment%20monitoring.png?width=334&height=223&name=environment%20monitoring.png)   Setra CEMS In Action: Exploring Use Cases [**View Now**](https://www.setra.com/blog/environmental-monitoring-in-action-setra-cems-software) ![SRF612_01_500px](https://www.setra.com/hs-fs/hubfs/SRF612_01_500px.png?width=223&height=223&name=SRF612_01_500px.png)   **Wireless Data Loggers for Cold Storage Monitoring** [**View Now**](https://www.setra.com/blog/wireless-data-loggers-for-cold-storage-monitoring) - [**](https://www.facebook.com/SetraSystems) - [**](https://twitter.com/setrasystems) - [**](https://www.youtube.com/user/SetraSystems) - [**](https://www.linkedin.com/company/setra-systems) - [**](https://www.instagram.com/setrasystemsinc/) [Service & Calibration](https://www.setra.com/support/service) | [Products](https://www.setra.com/products) | [Service/RMA](https://www.setra.com/support/service) | [Supplier](https://www.setra.com/support/supplier) | [Customer](https://www.setra.com/support/customer) | [Contact Us](https://www.setra.com/contact-us) | [FAQs](https://faq.setra.com) | [About](https://www.setra.com/about) | [Careers](https://careers.fortive.com/gems-setra/) | [Request Quote](https://www.setra.com/request-a-quote) | [Blog](https://www.setra.com/blog) Cookie Settings 159 Swanson Road Boxborough, MA 01719 | [orders@setra.com](mailto:orders@setra.com) [+1 (978) 263-1400 ](tel:+19782631400) Copyright © 2026 Setra Systems. 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