Periodic Safety Update Report
Efficient periodic safety
Understanding the complexities and regulatory demands of Periodic Safety Update Reports (PSURs) is crucial in the medical device industry.
Our aim is to assist manufacturers in navigating these challenges, ensuring that their devices continue to meet the highest standards of safety and efficacy throughout their market life.
Periodic Safety Update Report
What's a PSUR?
A Periodic Safety Update Report (PSUR) is a regulatory document required for medical devices, mandating a systematic evaluation of the accumulated clinical data and post-market experience related to a device's safety and performance.
This report, essential for maintaining regulatory compliance, must include an analysis of new or emerging risks, a reassessment of the risk-benefit balance, and a summary of any preventive and corrective actions taken.
The PSUR's frequency and format are dictated by regulatory guidelines, varying based on the device's risk classification and market approval conditions. It serves as a critical tool for regulatory bodies to monitor ongoing device safety and effectiveness after it has been released to the market.
Three good reasons to outsourcing PSURs
Outsourcing PSUR compilation enhances resource efficiency, allowing manufacturers to focus on core activities like research and development. It offers scalability and flexibility, adapting to varying workload demands without the need for expanding internal teams. Additionally, this approach is cost-effective, eliminating the overhead costs of training, specialized software, and maintaining a dedicated in-house team, leading to significant cost savings.
Periodic Safety Update Report
Our services
IASON consulting offers a comprehensive suite of PSUR-related services, including data collection and analysis, report writing, and regulatory consultation. Our positive track record demonstrates our expertise in delivering quality, compliant PSURs across all medical device categories.
