Thomas Regulatory

  The Clinical Evaluation Report (CER) is a detailed summary of the evaluation information relevant to the clinical use of a medical device. All clinical data sources are considered, as well as some nonclinical trial data that may influence the benefit-risk analysis of the device. Taken together, the information contained in the CER provides a thorough understanding of the safety and performance of the device and provides the basis for determining if the device has an acceptable risk-benefit ratio received for its intended use or not. The European Medical Device Registration (MDR) regulatory scenario is extremely dynamic, as are the regulations regarding CER. Therefore, to comply with these regulations and create compliant CERs, companies need to consult with regulatory experts. CER and Mandatory Data Elements General information about the medical device, such as the device's name and manufacturer The device's physical and technical characteristics, as well as its application A...

  Are you worried that passing FDA regulations for your medical device will slow your time to market and cause major headaches for your team? Speed ​​to market is a huge competitive advantage for companies in the equipment manufacturing industry. Avoidable delays can result in physical and indirect costs to your business, including loss of competitive advantage or regulatory penalties. While the best eQMS (Essential Quality Management Systems) and knowledge of regulatory requirements can help you achieve FDA cGMP compliance, your organization can also opt for expert help. Relying on a consultant to guide you through the process can make things easier and give you peace of mind. As the U.S. Food and Drug Administration's IVD and medical device review processes become more complex, working with an experienced FDA medical device consultant can make a significant difference in your marketing licensing and compliance efforts. Smart companies hire FDA consultants before they get stuck t...