INDUSTRIES

MEDICAL DEVICES

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Technician in sterile gown inspecting a medical device manufacturing machine.

Challenges
you can’t ignore

The medical device industry faces critical challenges when relying on manual environmental monitoring. Error-prone processes, time-consuming tasks, and the absence of real-time alerts put product quality and compliance at risk.

Inconsistent record-keeping complicates audits, while unreliable data increases the likelihood of non-compliance.

Without automation, ensuring accuracy, efficiency, and product integrity becomes an ongoing challenge in this high-stakes industry.

Continuous Environmental Monitoring for Medical Device Quality

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Operating room equipped with advanced medical devices and monitoring systems.
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Lifescience professional analyzing monitoring data to prepare for a compliance audit.
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Optimize Efficiency and Eliminate Errors

Manual data entry increases the risk of mistakes and slows down your operations. ATEK’s automated monitoring replaces manual processes with precise, reliable environmental tracking—saving time, reducing errors, and strengthening compliance. With less time spent on routine tasks, your team can focus on innovation and high-priority work.

Proactively Protect Product Quality

Environmental deviations can compromise product quality if not caught early. ATEK’s real-time monitoring and instant alerts enable immediate action, preventing small issues from becoming major problems. Stay compliant, reduce downtime, and protect the integrity of your medical devices.

Simplify Audit Preparation

Audits don’t have to be stressful. ATEK keeps your documentation accurate, consistent, and audit-ready with automated reports designed to meet regulatory standards. With easy access to reliable records, you can streamline audit preparation and minimize compliance risks.

Continuous Monitoring and Scalability

ATEK delivers continuous monitoring with built-in backup systems to keep your critical environments protected at all times. Our flexible, scalable solutions grow with your operations, allowing you to adjust sensor configurations and alert thresholds as your business evolves.

ISO 13485 LOGO
Medical Devices Regulations (SOR_98-282) LOGO
Health Canada Guidance on Quality Management Systems (QMS) LOGO
21 CFR Part 820 LOGO
FDA-logo
NIH Guidelines
ISO 14644 LOGO
ISO 14971 LOGO

SMARTER MONITORING IN 3 EASY STEPS

1. Select Sensors

Pick the sensors you need to track key environmental parameters.

2. Choose Connectivity

Decide how your data flows with the right transmission method.

3. Install and Set up

Get everything connected to the platform and start tracking real-time data instantly.

Learn About Our Risk-Free, Hands-On Demo
ATEK monitoring system displayed on computer, tablet, and connected temperature sensors.
TRY ATEK FOR YOURSELF

Get a Hands-On Demo &

a Risk-Free Trial.

 

See firsthand how ATEK can make monitoring and compliance effortless while keeping your products safe.