Ensuring EU-MDR Compliance: A roadmap for medical device manufacturers

With EU-MDR, pharmacovigilance has moved beyond compliance into a continuous responsibility—demanding proactive safety monitoring, robust vigilance reporting, and lifecycle documentation. For manufacturers, strong PV systems are now critical not only for market access but also for sustaining trust and patient safety.

At AWINSA Life Sciences, we partner with medical device manufacturers to strengthen their pharmacovigilance systems and deliver high-quality, compliant documentation that supports long-term safety and regulatory success.

Read our white paper, “Ensuring EU-MDR Compliance: A Roadmap for Medical Device Manufacturers,” to explore practical strategies for navigating these requirements.

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