At Quara Conseil, we offer a service to assist with the establishment of necessary procedures for Complaint Trending in accordance with Article 88 of the European regulation for medical devices. This includes preparing the necessary instances for review of Complaint Trending to ensure compliance with regulatory requirements.
Our team of experts have in-depth knowledge of the requirements outlined in Article 88, including the obligation for manufacturers to report any statistically significant increase in the frequency or severity of incidents that could potentially impact the benefit-risk analysis of the device. We can assist with the development of a post-market surveillance plan that specifies how to manage such incidents and outlines the methodology for determining statistically significant increases.
In addition, we can help ensure that appropriate measures are taken in response to assessments conducted by competent authorities, as required by the regulation. Our team is dedicated to supporting manufacturers in maintaining the highest standards of patient safety and public health