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A Trusted Partner for Comprehensive Instrument Calibration

A top priority for medical device manufacturers is the health and safety of patients, and the accuracy and precision of the instruments used in production is of the utmost importance. We have decades of experience managing calibration programs in highly regulated industries and provide innovative solutions to optimize even the most complex asset pools. Our skilled technicians can help you stay in compliance with ISO 13485 and 21 CFR parts 11 and 820.

Illumina's Quest for Precision: Unleashing Scientific Potential with Reliable Instrument Calibration

In the captivating world of genomic exploration, where the intricacies of life's code are deciphered and the frontiers of scientific knowledge are pushed ever further, one company stands at the forefront: Illumina. Known for its visionary genome-sequencing devices, Illumina has long understood that the pursuit of groundbreaking discoveries demands accuracy and precision. To that end, the company has embarked on a partnership with Tektronix, the experts in test and measurement equipment, to manage the calibration of the company’s wide array of instruments.

Learn more about Illumina active exchange

Illumina’s Headquarters
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A Cosmetics Manufacturer’s Journey to a Healthy Calibration Program

A large manufacturer in an FDA regulated industry found itself with repeated Form 483 findings. Tektronix partnered with the company to determine the right type of calibration services.

Learn more about a cosmetics manufacturer’s journey to a healthy calibration program

Top Five Risks for Medical Equipment Calibration Programs

The US Food and Drug Administration (FDA) consistently lists inadequate maintenance and calibration procedures as a top reason for issuing Form 483 observations to medical device manufacturers (hint: this is NOT a good thing). Within highly regulated industries, calibration program problems can leave you open to risks ranging from delays in time to market to increased liability and patient safety.

Learn more about the top five risks for medical equipment calibration programs

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A medical monitor displaying vital signs in a clinical setting

5 Key Equipment Calibration Essentials for Medical Device Manufacturers

The regular calibration of sensitive medical equipment test instrumentation such as temperature sensors, pressure transducers and weighing instruments is mandated by the U.S. Food and Drug Administration (FDA). Precise and repeatable measurements are crucial for test equipment being used in the medical equipment given the increased risk associated with non-compliance for medical device manufacturers. 

Learn more about 5 key equipment calibration essentials for medical device manufacturers

Reducing Risk and Improving Profitability for Medical Device Manufacturers

Calibration management systems that provide real-time visibility and consistency should be standard operating procedure for companies in regulated industries. Using a manual or hybrid process for calibration management can lead to missed calibration cycles. Instruments that are left uncalibrated can offer less accurate data, resulting in compromised product quality and downtime.

Learn about the differences between a traditional CMMS and web-based calibration program management, and find out how you can take your calibration program to the next level with CalWeb.

Learn more about reducing risk and improving profitability for medical device manufacturers

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Tips for Staying in Compliance with 21 CFR 820 and ISO 13485

Learn about the key differences between the two standards and a get a quick guide to choosing a calibration provider that can help you build an ironclad calibration program.

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Tips for staying compliant with FDA Regulations and ISO Standards in the Medical Device Industry