Ensuring Long-term Product Quality and Efficacy through Streamlined Postmarket Surveillance Processes including Integration of eQMS for Complaint Intake, Employment of Stringent Postmarket Cybersecurity Strategies and Proactively Preparing for EU MDR Compliance
The data required to secure regulatory approval for new products is extensive, but the need to report quality and safety information highlighting a device’s long-term performance does not end with the product launch. As healthcare providers, consumers and regulators are continually looking for more real world evidence supporting product performance the need for streamlined postmarket monitoring activities has concurrently grown as surveillance teams look to ensure device quality. Building on conference knowledge share and success of this annual conference, the 2020 program will showcase industry experts within postmarket operations, who as presenters will share experiences and knowledge that will be of great benefit to all attending delegates. Industry leaders will address a range of topics from proactively preparing for compliance with the 2020 EU MDR deadline, implementing comprehensive complaint escalation processes, and exploring the FDA’s Voluntary Manufacturing Summary Reporting program.