PERIODIC SAFETY UPDATE REPORTS
We offer periodic safety update report (PSUR) services to help you meet the regulatory requirements for safety monitoring of medical devices. Our team of experts has extensive experience in PSUR preparation and can assist you in preparing reports that meet the relevant regulatory requirements, including the Medical Device Coordination Group (MDCG) guidance.
A PSUR is a key element of the safety monitoring of medical devices and is required by regulatory authorities in including around the world, including the EU. Our PSUR services cover the following areas:
What we offer
Data Collection
We collect safety data from a variety of sources, including clinical studies, post-market surveillance data, adverse event reports, and other relevant information.
PSUR Writing
We prepare comprehensive PSURs that meet the regulatory requirements, including the MDCG guidance. Our reports include a summary of the safety data, an analysis of safety concerns, and conclusions regarding the safety and effectiveness of the device.
Data Analysis
We analyse the safety data to identify potential safety concerns and trends, and to evaluate the safety and effectiveness of the device.
Regulatory Submission Support
We provide ongoing support throughout the regulatory submission process, ensuring that your PSURs are complete, accurate, and meet all regulatory requirements.
We are experienced in regulatory requirements for PSUR preparation and MDCG guidance.
Our team of experts has a proven experience with the regulatory requirements for PSUR preparation, including the MDCG guidance, and can assist you in preparing reports that meet these requirements. We are committed to providing high-quality, reliable services that meet the needs of our clients. Contact us today to learn more about our PSUR services and how we can help you meet the regulatory requirements for safety monitoring of your medical device.