Periodic Safety Update Reports - IVDs

Post-Market Surveillance

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Delivering Quality Periodic Safety Update Reports - IVDs

The prerequisite for a periodic safety update report (PSUR) is new under the EU IVDR. Numerous manufacturers are working hard to allocate the fundamental assets for full IVDR execution, including post-market observation exercises like PSURs.

Graywolf Research Group has the tools, system, and industry expertise to guarantee your PSURs are compliant and submitted on time.

The aim behind the prerequisite for PMS Reports and PSURs is to further develop devices and the advantages they offer to patients. We assist you with meeting this objective by guaranteeing that your frameworks are all incorporated and that PSURs line up with PERs and your PMPF plan.

Graywolf Research Group conveys integrated services to guarantee that information from PMPF inputs (IFUs, PMS information, and PER) gets taken care of into PSUR, PER, and PMPF reports.

Maximizing Your Experience

Whether for specific projects or all things regulatory, add capacity to your internal team for assigned product lines with our subject matter expert support.