Medical Device Analytical Testing Outsourcing Market: Key Companies & Market Share InsightsA Chapter by Markets InsightsThe global medical device analytical testing outsourcing market size was valued at USD 5.0 billion in 2021 and is anticipated to grow at a compound annual growth rate (CAGR) of 8.1% over the forecastThe global Medical Device Analytical Testing Outsourcing Market size is expected to reach USD 10.6 billion by 2030, registering a CAGR of 8.1% over the forecast period, according to a new report by Grand View Research, Inc. Several medical device companies outsource analytical testing operations to decrease business risks, accelerate product market entrance, and lower expenses. As a result of this considerable rise in spending levels, medical device Original Equipment Manufacturers (OEMs) quickly shift to outsourcing as a cost-cutting technique. Medical device testing remained consistent in 2021. The testing requirements of Medical Device Manufacturers (MDMs) reflected variations in the medical/healthcare market as it recovered from the COVID-19 slowdown. In 2021, the need for European Medical Device Regulation (MDR) remediation standards, as well as the ever-increasing regulatory demands in the Leachables & extractables (E&L) arena, accounted for a significant portion of the testing effort. However, due to delays and a lack of external resources and labor, labs’ ability to expand capacity has been limited. Regulatory authorities are focusing on testing technique validation, especially data quality, including repeatability and reproducibility. There is also a trend toward more deterministic testing methods. This enables companies to acquire more statistically reliable data to determine if their products meet the criteria. For example, the medical device sector and testing labs confront considerable hurdles in adopting ISO 10993-18:2020 E&L testing regulations while still meeting FDA expectations. The FDA had requested the use of conservative techniques to reduce areas of ambiguity or potential inaccuracy in E&L testing throughout 2021. Related Press Release@ Medical Device Analytical Testing Outsourcing Market Report Medical Device Analytical Testing Outsourcing Market Report Highlights
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1 Review Added on September 30, 2022 Last Updated on September 30, 2022 Tags: Medical Device Analytical Testin AuthorMarkets InsightsFelton, CAAboutAbout Us: Hexa Research is a market research and consulting organization, offering industry reports, custom research and consulting services to a host of key industries across the globe. We offer c.. more..Writing
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