The Medical Devices Regulation (MDR) 2017/745, a comprehensive and stringent regulatory framework, has presented significant challenges for medical device manufacturers seeking to enter or maintain their presence in the European market. Among the key areas of concern are clinical investigations. The EU Authorized Representative serves as a valuable partner, offering expert guidance, regulatory compliance support, effective communication, and coordination throughout the clinical investigation process. RQMIS is an EU Authorized Representative, and we are experienced in guiding clinical investigations.
Under the MDR, clinical investigations play a pivotal role in demonstrating the safety and performance of medical devices. Conducting clinical investigations involves complex processes, regulatory requirements, and ethical considerations.
The EU Authorized Representative possesses extensive knowledge and experience in managing clinical investigations. They ensure that clinical investigations are conducted in accordance with applicable EU regulations, including obtaining necessary authorizations, managing documentation, and addressing ethical committee requirements. RQMIS possesses extensive knowledge of EU regulations and ensures that your clinical investigations align with the MDR requirements. We assist in obtaining necessary authorizations, managing documentation, and managing regulatory queries and/or interactions. Our proactive approach ensures compliance throughout the clinical investigation process.
Partnering with a reputable EU Authorized Representative can be a key strategy for manufacturers to not only survive but thrive in the European market under the MDR 2017/745. RQMIS stands as your trusted partner in achieving MDR compliance for clinical investigations and QMS requirements. Our expertise, regulatory knowledge, and comprehensive support enable medical device manufacturers to navigate the complexities of the MDR with confidence. Reach out today to find out how we can help you!