Medical device manufacturers around the globe are required to comply with regulations regarding Design Control. This Insight Brief examines the key role that Quality plays in this process by monitoring and managing an organization's Design Control Process, ensuring it is effectively implemented and integrated with other key systems within the organization.
Medical device manufacturers around the globe are required to comply with regulations regarding Design Control to ensure that specific requirements for a device are met. Device manufacturers are also required to maintain a Quality Management System to ensure safety and efficacy. Here we’ll look at the role of Quality Management in Design Control and how both disciplines improve not only the safety and efficacy of the device, but the performance of the business.
I asked Pam Weagraff, MBA and Director of IQVIA MedTech Regulatory, to discuss the importance of having a quality management system (QMS) and the right resources to support product development and post-market maintenance.
The importance of having a Quality Management System (QMS)
Weagraff stated, “For any company planning to participate in the MedTech sector, understanding and advocating for a robust and finely tuned quality management system can be a competitive advantage rather than just a cost of doing business, and is imperative.“ She went on to add that a robust, finely tuned Quality Management System (QMS) aids in the delivery of high-quality MedTech products to the market faster, and it keeps these same quality products on the market at a lower cost. Companies that do not invest in or support their QMS are well-known to experience unnecessary project delays and slower time-to-market, as well as experience the high cost of product complaints and recalls. “Quite simply, support for a robust and finetuned QMS is good business practice!” Design Control is one of those QMS processes.