Medical device quality control inspection is considered to be highly significant in ensuring safe delivery of medical devices from their place of origin to the market. However, tremendous development in medical technologies have challenged the medical device packaging industry to ensure quality and reliability in packaging.
Adding to that, drug contamination is a serious concern in any medical industry- specifically for Class III medical devices. Class III medical devices are understood as devices that sustain or support life and are implanted, or present potential unreasonable risk of illness or injury. Since these devices are directly placed into human bodies, proper packaging is required to ensure quality of the product until it reaches the patient. Any breach in the packaging can cause contaminants to enter the device, causing major health risks. Hence, appropriate package integrity testing and seal quality inspection of Class III medical devices are required so as to ensure seal quality and sterile barrier integrity are maintained.