The Medical Device Shelf Life Testing Market involves assessing the stability and functionality of medical devices over time to determine their shelf life. This testing is critical for medical device manufacturers to ensure their products remain safe and effective throughout their labelled expiry date.
The global medical device shelf life testing market size was valued at USD 3.2 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 7.2% from 2022 to 2030. Growth drivers include increasing regulations requiring shelf life testing, the growing medical devices market overall, technological advancements in testing capabilities, and rising focus on quality and safety from both manufacturers and regulatory bodies alike.
Shelf life testing usually involves exposing medical device product samples to various environmental conditions over different time intervals and performing functional testing at set points. Tests may include studying the effects of temperature, humidity, oxidation, radiation, mechanical wear and tear, and transportation conditions.
The most common methods used are real-time testing, accelerated testing, and simulated-use testing. The type of testing method depends on product-specific regulatory requirements as well as characteristics of the device itself.
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Key end-use segments covered in the shelf life testing market include medical device companies, test laboratories, and academic and research institutes. In vitro diagnostic medical devices and hospital equipment/surgical instruments make up the majority of devices going through shelf life testing.
Geographically, North America was the largest market for medical device shelf life testing in 2021, driven by a prominent medical devices industry coupled with stringent regulatory mandates around safety and efficacy. The Asia Pacific market is forecast to grow rapidly due to increasing medical device manufacturing in the region.
