Validating Medical Device Assembly, Packaging, & Sterilization
Medical device packaging and sterilization validation are required for FDA 510(k) submissions yet are often causes of delay. Sterile packaging validation is a vastly misunderstood topic in its own right but becomes even more complicated when considering it involves the additional coordination of manufacturing, product shelf life, and sterilization validations all under a complicated array of regulations. This white paper explains how these validation requirements must be coordinated for medical device manufacturers to get their single-use medical devices to market faster.
For more information contact J-Pac Medical
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25 Centre Road, Somersworth, NH, 03878, United States