EU MDR, FDA, CMDR 

Comprehensive and project-specific regulatory expert consulting and writing with a focus on;

Clinical Evaluation Plans

Our clinical evaluation experts will support you to conduct a comprehensive gap analysis and systematically guide you to develop the scope and methodological approach to a robust clinical evidence identification which is then employed within the clinical evaluation report. 

Clinical Evaluation Reports

Developing and maintaining CERs requires a structured and continuous process.  We support comprehensive clinical evidence identification and clinical literature appraisal, detailed analysis of available clinical evidence related to the device, and alignment of clinical data. The goal is to demonstrate compliance with the regulatory requirements for safety and performance in relation to device indications and intended purpose. 

Summary of Safety and Clinical Performance

According to the Regulation (EU) 2017/745 on medical devices,  the manufacturer of implantable devices and class III devices (other than custom-made or investigational devices) must develop a summary of safety and clinical performance (SSCP). The goal is to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device to healthcare professionals and patients where applicable. 

Clinical and regulatory writers at Aolete, have a detailed understanding of the Regulation (EU MDR) and guidance documents (MDCG and Meddev Rev 4) and will provide a step-by-step process to create regulatory-compliant SSCPs intended for both users/healthcare professionals and patients.