Chicago, USA – Modern Medicine and Medical devices work side by side to prevent, diagnose, and treat severe diseases of the present world. To ensure the health practitioners’ and patients’ ultimate safety, Europe has introduced a new Medical Device Regulation (MDR) that requires medical device manufacturers to implement the most accurate business practices to enable and enhance the safety management of the medical equipment produced or supplied in the region. The MDR demands the manufactures to make their devices traceable by a Unique Device Identification number. The regulations aim to ensure high-grade safety and health-supporting innovation at the same time.
Before launching a new medical device in the European market, the EU MDR requires that the device must go through extensive scrutiny. Even after the product is on the shelves, post-market vigilance is also needed to maintain the device safety quality. Producing a medical device is already a complicated process but making them EU MDR certified is a demanding task as well. The detailed literature review and the Clinical Evaluation Report have to be faultless to ensure the certification in the first attempt. The job is very time consuming and the most challenging aspect of the entire process.
Cite Medical provides literature search and clinical evaluation report services to medical device manufacturers to enable them to get MDR certification quickly in the stipulated time. Cite Medical is operating in the market for over three years now and has reviewed thousands of articles and monitored numerous products. With our expert result-driven processes, we conduct a thorough medical device literature search, which is the foundation of an authentic clinical evaluation report. Our services have a 100% success rate in Europe and several other countries.
The Final submissions must be thoroughly researched, beautifully written, and well organized to pass the notified body review process. The competent research and medical writer team at Cite Medical have all the right skills to create a comprehensive faultless clinical literature review of the medical devices that will help achieve the EU MDR goals speedily. To achieve consistency in the formatting and maintaining accuracy, we have released an innovative software platform that will efficiently polish the final reports. The software platform is one of a kind and created through extreme precision to ensure that the reviews and reports meet the notified bodies’ stringent evaluations. This in-house software platform is a synergy between advanced software engineering and experienced regulatory affairs medical writers The software platform will not only ensure uniform, concise formatting throughout the literature review and reports but also increase the efficiency of our writers and enables us to complete the tasks in a fixed time frame.
Company Name: Cite Medical LLC
Contact Person: Ethan Drower
Email: Send Email
Phone: (312) 6007326
Country: United States