Medical Equipment Calibration Services Market Recent Trends by Forecast to 2028

Posted on 2022-08-17 by researchinsights in Internet & Online // 0 Comments

Medical Equipment Calibration Services Industry Overview

The global medical equipment calibration services market size was valued at USD 1.0 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 9.4% from 2021 to 2028.

This growth can be attributed to advancements in the medical device sector, stringent regulations pertaining to calibration of devices, as well as increasing awareness about preventative medical equipment maintenance. Other factors, such as increasing demand for refurbished medical equipment and rising corporate investments in healthcare infrastructure, are also driving the market growth. COVID-19 has created immense pressure on the healthcare industry. It has brought challenges to all the businesses & industries, but none more than hospitals & healthcare facilities.

Gather more insights about the market drivers, restrains and growth of the Global Medical Equipment Calibration Services Market

Medical equipment maintenance has become even more essential than in normal times. It is subject to stringent regulations owing to the substantial health risks in the sector. The global COVID-19 pandemic is further reinforcing these constraints. Besides, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued recommendations to laboratories & manufacturers who require outside engineers to calibrate their equipment during the COVID-19 pandemic. For companies that need their equipment maintained or calibrated, the MHRA has provided numerous options.

For instance, if an engineer is available to visit the site, the company should assess the risk of COVID-19 transmission and take precautions to keep them apart from other employees and adequately monitored. MHRA has allowed electronic signatures on protocols and site visit documents. Companies that are unable to get even remote support can benefit from the MHRA’s instructions. In that case, the MHRA encourages companies to keep track of their quality systems and consider the risk of postponing maintenance.

If a piece of equipment is taken out of operation after a risk assessment, any remaining maintenance tasks should be completed before it is reintroduced. Calibration ensures the instrument’s precision and accuracy to reduce measurement errors. To promote improved patient safety, equipment calibration is essential in the healthcare industry. The FDA has a code of regulations for medical device calibration requirements Part 820, QSR, Section 72, which deals with inspection, measuring, and testing equipment stipulates that medical device calibration criteria must address the control of certain parts of the medical device.

Regulatory agencies accept the necessity of precision in medical instruments, and regulatory criteria for instrument calibration have been established. Since device makers prioritize patient health and safety, device accuracy and precision are critical. Instrument calibration services that adhere to regulatory requirements defined by governing organizations are becoming increasingly popular in the medical, pharmaceutical, and biomedical industries.

According to the FDA’s medical device calibration regulations, the manufacturers must have systems in place that provide clear guidance and limits in terms of precision and accuracy. Whenever a medical device fails to fulfill these precision and accuracy standards, the FDA will assess whether it poses a risk of damage to the patient in the form of an adverse impact. If these flaws are detected, the producer of the device must calibrate it to enhance quality until the standards are fulfilled. All of these steps must be documented.

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