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PMPF plans and reports are fundamental components of post-market surveillance (PMS) prerequisites for IVDs in the EU under IVDR. Graywolf Research Group gives thorough PMS services that incorporate master support for making and keeping up with PMPF reports so they line up with other applicable frameworks and PMS activities.
Graywolf Research Group creates PMPF plans that line up with your performance evaluation reports (PERs) and fortify weak spots in performance evidence. We likewise team up with you to foster plans that you can execute effectively.
EU IVDR compliance expects that you present a PMPF plan as a component of your specialized documentation to affirm the well-being, performance, and legitimacy of your device. With the former notified body initiative and a committed clinical and post-market surveillance team, we have the team to help you.
IVDR requires progressing reporting and updates to documentation to exhibit that your arrangement was followed. Graywolf Research Group can assist you with making frameworks to guarantee that reports are refreshed productively so your PMPF documentation is dependably consistent.
Whether for specific projects or all things regulatory, add capacity to your internal team for assigned product lines with our subject matter expert support.
