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PMPF plans and reports are fundamental components of post-market surveillance (PMS) requirements for IVDs in the EU under IVDR. Graywolf Research Group gives thorough PMS services that incorporate expert support for creating and maintaining PMPF documents so they line up with other significant systems and PMS activities.
Let Graywolf Research Group specialists carry out procedures in view of best practices to improve your resources and guarantee execution before your certification audit.
EU IVDR compliance expects that you present a PMPF plan as a component of your technical documentation to affirm the performance, safety, execution, and scientific validity of your device. With the former notified body initiative and a devoted clinical and post-market surveillance group, we have the mastery to help you.
Graywolf Research Group can create and maintain a reporting schedule so your team can focus on everyday tasks without stressing over PMPF compliance.
Whether for specific projects or all things regulatory, add capacity to your internal team for assigned product lines with our subject matter expert support.
