While design control has been a quality system requirement since 1996, many medical device organizations struggle to understand these requirements, as well as when to start the process and how to maximize the benefits of the system. For example, it is often mistaken that a design control process must be complex to meet the regulatory requirements and to ensure delivery of a safe product that meets customer demands. Additionally, another common mistake made by device manufacturers is initiating the design control system process later in the overall design process. Understanding the elements of design control will help a company focus on the important aspects of the product while reducing the risk to the patient and getting the device to market faster and more efficiently. By attending this webinar, you will learn how to get the most from your design control process.
Time will also be allotted for Q&A.
View the recorded webinar here.
About the Presenter:
Linda Mummah-Schendel has over 30 years of regulatory experience in the medical device industry. She has developed, implemented and trained on new and re-engineered Quality Systems, including projects related to continuous improvement, product non-conformance, CAPA systems and root cause analyses. She has led multiple project management and development activities for a wide variety of medical devices and combination drug/devices, including IVD and biopharmaceutical products. An expert in GMP regulation and ISO 13485 Quality System requirements, Ms. Mummah-Schendel also has extensive knowledge and experience surrounding IDE and PMA submissions.