Medical devices (MD) are specific products that are used at different stages of medical therapy from the diagnosis, throughout the treatment and monitoring. Whether your medical device is an active implant, an in-vitro diagnostic (IVD) or a classic medical device, compliance with the essential principles of safety, performance and effectiveness must be demonstrated.
Developing a regulatory pathway to evaluate and improve technical documentation, including evaluation of your analytical and clinical data, deploying an ISO 13485 certified quality management system (QMS) and assembling the essential pieces of evidence for regulatory bodies are essential to the successful design, development, and industrialization of an IVD.
Join Philippe Etter and Silvia Anghel for guidance on developing technical documentation, implementing risk management processes and building evidence to meet regulatory compliance.
Understand the importance of developing and implementing risk management processes and activities.
Review technical documentation according to the latest ¨IVDR requirements and applicable guidance
Review the guidance on labeling and instructions for use.
Learn what is needed for successful submission to notified and regulatory bodies.