Support for PMS, PMCF, and PSUR Activities
Post-Market Surveillance (PMS)
Effective PMS is essential for monitoring the safety, performance, and risk profile of medical devices after they have been placed on the market. Our team of experts provides comprehensive support in establishing and implementing PMS systems tailored to your specific devices. We assist you in developing PMS plans, defining data collection methods, analyzing and interpreting data, and identifying any adverse events or trends that may require further action. By partnering with us, you can ensure compliance with regulatory requirements and take proactive steps to address any emerging safety concerns.
Post-Market Clinical Follow-up (PMCF)
PMCF activities play a crucial role in gathering additional clinical evidence to support the safety and performance of medical devices. Our consultancy services cover the design and implementation of PMCF studies, including protocol development, data collection, analysis, and reporting. We assist you in identifying the most appropriate PMCF methodologies and strategies to generate the necessary clinical data, ensuring compliance with regulatory expectations. Our team works closely with you to ensure that your PMCF activities contribute to the ongoing assessment of device performance and support future regulatory submissions.
Periodic Safety Update Report (PSUR)
PSURs are an integral part of the post-market surveillance process, providing a comprehensive overview of the safety and performance of medical devices. Our experts assist you in compiling and reviewing the required data, preparing PSURs, and ensuring compliance with regulatory timelines and guidelines. We help you analyze adverse events, update risk management files, and address any emerging safety concerns identified through the PSUR process. By leveraging our expertise, you can demonstrate your commitment to patient safety and regulatory compliance through robust PSUR submissions.
Regulatory Compliance and Risk Management
Our support for PMS, PMCF, and PSUR activities is driven by a deep understanding of regulatory requirements and best practices in risk management. We assist you in aligning your post-market activities with relevant regulations and guidelines in Brazil, Japan, USA, Australia, Canada, and other target markets. By leveraging our expertise, you can proactively identify and mitigate potential risks, ensure compliance with post-market obligations, and maintain the safety and efficacy of your medical devices.
