Most disposable medical products are comprised of thermoplastic materials. Manufacturers in the thermoplastic industry periodically institute formulation changes. As mandated by regulatory requirements, the medical device manufacturer must evaluate if a change impacts product safety and efficacy. Minimizing financial impact of validations is critical. A system of communication and engineering was developed to address these challenges. The communication loop enables tracking of milestones during the approval process to ensure timely change implementation. The engineering system provides centralized testing to be utilized within the company. Successful implementation of this system is applicable for organizations of all sizes.
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