Todd Neal, Product Manager, IQVIA Quality Compliance
For any MedTech company, understanding and supporting a robust and finely tuned internal Quality Management System (QMS) can be a competitive advantage rather than just a cost of doing business. And it’s imperative. Medical device manufacturers around the globe are required to maintain a Quality Management System to ensure safety and efficacy. Subsequently, they are also required to comply with regulations regarding Design Control for medical devices to ensure that specific requirements for their devices are met.
Whether an organization is adhering to the FDA and its Quality Systems Regulation (QSR), the European Union and its Medical Device Regulation (EU MDR), or other regulatory authorities and standards for Design Control, it is important to manage the ongoing Quality Management process and provide documented evidence that a well-defined, controlled process is in place and has been properly executed. Under EU MDR, not only must technical documentation be current and demonstrate conformance with requirements, but it must also reflect the development stages applied to the design of the device. (more…)