Package Testing & Validation
Regulatory agencies’ concern for labeling and packaging of a medical device leads to product quality scrutiny. Medical device package validations are a key component of all medical device design history files and regulatory submissions. Whether the device is sterile or nonsterile, packaging of the product to ensure it arrives as intended is of the utmost importance.
Our technical experts approach these validations by looking at the components of the packages both individually and as a whole. The packaging validation consists of three components: package and seal integrity testing, accelerated aging or shelf life stability, and simulated distribution testing. Our validation and ongoing testing incorporates the aging of the product packaging to support shelf life stability and product expiration labeling. In addition, our validation design will verify package integrity, seal strength and burst properties evaluation, and distribution of the final finished devices – whether boxes or cartons delivered remain intact.