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The periodic safety update report (PSUR) is a requirement under the EU MDR. Graywolf Research Group has the frameworks, tools, and industry experts to guarantee your PSURs are consistent and submitted on time.
PSURs should order and evaluate information from different frameworks and sources. Our team will adverse events, serious incidents, and gather and analyze complaint data, FSCAs, data from public databases for relevant information about similar devices, CAPAs, product usage for all types of devices, and recalls.
As per the data available, our team will create a report that incorporates key components, for example, PMS data, reasoning and depiction of any corrective actions taken, review of the risk-benefit analysis, vigilance reporting, conclusions of the risk-benefit determination, current market status, and summarize any PMCF findings.
As far as we can tell with PMS Report and PSUR submissions under MDR, data analysis is possibly the main component — and perhaps of the greatest gaps. If your reports are missing out on something, you can expect questions from the reviewers. Graywolf Research Group can examine data from different sources to identify trends in adverse events and reviews.
Whether for specific projects or all things regulatory, add capacity to your internal team for assigned product lines with our subject matter expert support.
