Real Time Aging
Real time aging is performed in parallel with accelerated aging in order to support and verify accelerated aging conclusions. It is recognized that in some cases products are technologically obsolete before a real time aging project can be completed.
The FDA provides guidance regarding medical device shelf life determination and advises manufacturers to consider several parameters including chemical and physical. The European Medical Device Directive (MDD) requires all sterile medical devices to have an expiration date. Documented shelf life evidence must exist to substantiate shelf life claims made by the manufacturer.
DDL carries out accelerated aging and real time aging at both its Minnesota and California laboratories.
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