Selling your medical devices and in vitro diagnostic (IVD) products in the European Union
(EU) requires a keen understanding of the intricate web of regulations.
At FiunEx, we're here to guide you through the complexities, starting with the crucial
role of the "person responsible for regulatory compliance" (PRRC).
Why the PRRC Role is Essential:
Mandatory Compliance: The EU Medical Device Regulation (MDR) and In Vitro Diagnostic
Regulation (IVDR) mandate the appointment of a PRRC to sell your products in the EU
Small and Micro Companies' Challenges: Small and micro companies, often challenged by
resources, might find it hard to secure qualified Regulatory Affairs and Quality Systems
(RAQS) experts for the PRRC role. These resources can also come with a hefty price tag.
FiunEx Expertise at Your Service:
Through our collaboration with Qarad, an industry leader with over 20 years of
experience, we bring to you an outsourced center of excellence for all quality and
regulatory matters. Our cost-effective approach ensures that your journey towards EU
market compliance is efficient and hassle-free.
Structured PRRC Designation Process:
FiunEx takes pride in a meticulously structured process for designating a PRRC. We ensure
that the FiunEx designated PRRC is deeply engaged in your company's processes, aligning
seamlessly with your goals and ambitions.
Navigating EU regulations is no longer a daunting task. Choose FiunEx PRRC Support and
empower your business with the knowledge and expertise needed for EU market success.
Person Responsible for Regulatory Compliance (PRRC)