What Sets Us Apart

At Quantus, we understand that precision and compliance are paramount in the medical device industry. Our services are carefully tailored to meet the rigorous standards required by medical device manufacturers. By harnessing cutting-edge technology and a deep understanding of your specific industry needs, we deliver services that not only meet but exceed FDA and international regulatory requirements.

In the demanding and constantly evolving field of medical device manufacturing, where efficiency and precision are critical, Quantus stands as your reliable partner. We offer a comprehensive range of specialized services designed to enhance product quality and ensure operational excellence.

Exceeding Medical Device Standards with Precision and Reliability

Onsite Services

  • Calibration Services

    Calibration Services

    Quantus delivers on-site NIST Traceable Calibration for life sciences lab equipment, manufacturing process systems, and supporting utilities.

  • Cleanroom Certification

    Cleanroom Certification

    Providing certification services for PECs, cleanrooms, and sterile processes, ensuring compliance ISO 14644 and EU Annex 1.

  • Microbial EM Sampling

    Microbial EM Sampling

    Microbiological testing services for controlled environments, includes air, surface, personnel, chemical,  water, and compressed gas sampling.

"The technicians here do anoutstanding job. I truly appreciatethe responsiveness of the customersupport team and their proactiveapproach to scheduling."

Ken, Ellume

We Have Answers To Your Problems

Frequestly Asked Questions

What types of calibration services does Quantus provide for medical device manufacturers?

At Quantus, we offer comprehensive NIST Traceable Calibration services tailored to the unique requirements of medical device manufacturing. Our services include calibration of diagnostic and production equipment, ensuring precise measurements and compliance with industry standards.

Whether you need calibration for dimensional, cleanroom manufacturing, or laboratory instruments, our expert team ensures your equipment operates at peak performance, maintaining the critical accuracy required for your products.

How does Quantus ensure compliance with ISO standards in cleanrooms?

Quantus is committed to upholding the highest standards for cleanroom certification, adhering strictly to ISO 14644 and EU Annex 1 guidelines. Our certification process includes thorough testing of particulate levels, airflow, pressure, temperature, and humidity, along with comprehensive validation of cleanroom design and operation.

Our detailed reports provide actionable insights, helping you maintain environments that are not only compliant but also optimized for the manufacturing of safe and effective medical devices.

Can Quantus help optimize our environmental monitoring systems for better compliance and efficiency?

Yes, Quantus specializes in enhancing environmental monitoring systems to ensure compliance with regulatory standards while improving operational efficiency. Our services include setting up and optimizing microbial and chemical sampling, EMPQs from planning through execution, and fully integrated lab analysis tailored to your specific needs.

We provide robust support in air, surface, and personnel monitoring, as well as in the critical areas of water and compressed gas testing, to ensure your controlled environments consistently meet the stringent requirements necessary for medical device production.


Get in touch with us today and we can help.

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