Title: Clinical Evaluation, Clinical Performance and Safety of Medical Devices
Highlights: The development and approval of medical devices differ from those of new drugs or biologics. The inherent difference between medical devices and drugs have implications for clinical research, safety assessment, and regulatory submission. The adoption of new European Union (EU) Medical Device Regulation (MDR), have changed the legal framework for medical devices across EU and the globe as they pose many new questions and challenges for the medical device industry. A clinical evaluation is required to verify the safety and performance of a medical device, including its clinical benefits during pre-market approval while a postmarket surveillance (PMS) to collect, record, and analyze relevant data on the quality, performance, and safety of a device throughout its lifetime to determine, implement, and monitor any corrective and preventive actions. In addition, a system for risk management is required to minimize risks or prevent incidents related to medical devices along with field safety corrective actions. The new MDR requires a PMS plan, report and a Periodic Safety Update Report for medical devices, which is a relatively new concept.
This virtual workshop will be focus on generating clinical evidence, managing the safety of medical devices during pre- and postmarket approval, and discuss key consideration for the benefit-risk assessment of medical devices throughout their lifecycle.
Who should attend: Medical Writers, Drug and Device Safety Scientists, Clinical Researchers, Medical and Regulatory Affairs Professionals, Students, and Academicians
Workshop Organizer: Bindu Narang (Labcorp Drug Development)
Taskforce Committee: Ashish Indani (TCS), Sundeep Agarwal (Datt MediProducts Pvt. Ltd.), Priyadarshini Arambam (Batra Hospital)