You wouldn’t take your Mom out to dinner on Mother’s Day without a reservation, nor should you leave packaging integrity up to chance. The US FDA requires medical device manufacturers to implement risk management for packaging into the design and development process. Risk management is how risks in designs and processes are identified, mitigated, and controlled, therefore ensuring a higher level of patient safety. For moderate and high risk failure modes, packaging system performance should be properly vetted for safety and efficacy. Our lab offers the entire scope of testing services to ensure your packaging system hits the market with confidence.
Often product development teams overlook packaging when moving through design control and risk management activities. Key requirements can easily be missed, which could lead to a recall. In this event, the FDA would state that the company hasn’t considered a particular packaging risk, nor have they done anything to identify or mitigate that risk, therefore the product isn’t safe to be in the market. This is the biggest nightmare a medical device company can encounter. PCL can work with your team during design and development to craft a full risk management plan along with FMEAs. Our test lab then offers the full suite of transit, aging (F1980), and integrity testing needed to prove out performance. We can’t guarantee confidence in your Mother’s Day gift, but we can ensure it in your packaging system!