The global medical equipment calibration services market size is expected to reach USD 2.2 billion by 2028, registering a CAGR of 9.4% over the forecast period, according to a new report by Grand View Research, Inc. The market is majorly driven by the demand for refurbished medical equipment, stringent regulations, and market strategies, such as total annual calibration service subscriptions, provided by service providers.
Calibration ensures the highest level of precision for medical devices while also lowering costs, making it an essential component of biomedical cGMP and FDA compliance. As medical equipment measurements have a significant impact on public health and safety, pharma and biotech businesses must adhere to ISO/IEC 17025:2005 regulations throughout testing, calibration, and sampling.
The calibration requirements for equipment are defined in title 21 of the FDA’s Code of Federal Regulations. As per section 820.72, manufacturers are required to inspect, measure, and test equipment to ensure that it is adequate for its intended purpose and capable of producing correct findings. Noncompliance with FDA equipment calibration standards can result in significant financial fines. It ranges from $100,000for individual errors that do not result in a patient's death to $500,000 for a noncompliance issue that results in a patient's death.
The COVID-19 pandemic has had a major impact on the market The healthcare sector has experienced unprecedented difficulty as a result of governments' clear social distancing attempts to prevent the virus from spreading. This has affected the sales reps, medical scientific liaisons, and pharma personnel's face-to-face interactions.
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The third-party calibration services segment dominated the market with a share of 40.2% in 2020. This is owing to the quickest turnaround time for equipment calibration results when using a third-party source on-site
The clinical laboratories segment is projected to witness the fastest CAGR of 11.2% over the forecast period, as these labs prefer to subscribe to annual or periodic service plans that cover the validation of all of the lab's instruments
North America account 3d for the maximum revenue share of 37.0% in 2020 due to factors, such as the increasing number of medical devices recalls as technology becomes more sophisticated
Asia Pacific is anticipated to register the fastest CAGR of 10.3% over the forecast period due to the strict regulatory regulations and increasing public awareness about the quality of services given in hospitals and laboratories
Grand View Research has segmented the global medical equipment calibration services market based on service, end user, and region:
Medical Equipment Calibration Services Outlook (Revenue, USD Million, 2016 - 2028)
Original Equipment Manufacturer (OEM)
Medical Equipment Calibration Services End-user Outlook (Revenue, USD Million, 2016 - 2028)
Medical Equipment Calibration Services Regional Outlook (Revenue, USD Million, 2016 - 2028)
Middle East & Africa
List of Key Players of Medical Equipment Calibration Services Market
Biomedical Technologies Inc.
NS Medical Systems
JM Test Systems
Hospicare Equipment Services Corp.
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