Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Zamann Pharma Support offers a service designed to oversee and coordinate all aspects of the client’s EU registration project for Medical Devices. With a focus on efficiency and compliance, our experienced project managers ensure seamless execution from start to finish.
Developing a detailed project plan outlining key milestones, timelines, and resource requirements for the EU registration process.
Coordinating with internal and external stakeholders to define roles and responsibilities, allocate resources effectively, and ensure alignment with project objectives.
dentifying potential risks and challenges associated with the EU registration process and implementing proactive measures to mitigate these risks.
Monitoring project progress closely, identifying deviations from the plan, and implementing corrective actions as necessary to keep the project on track.
Ensuring that all activities related to the EU registration project adhere to relevant regulatory requirements and standards, including EU Medical Device Regulations (MDR).
Providing guidance and support on regulatory submissions, documentation requirements, and compliance strategies to facilitate successful registration of medical devices in the EU market.
Understanding and processing the EU regulations for Medical Devices and IVDs requires precision and insight. Our support is personalized to guide your product through the EU regulatory landscape, from initial classification to successful registration.
Zamann brings extensive experience with EU Medical Devices and IVDs regulations, offering reliable expertise to simplify the path to compliance. We provide strategic guidance, ensuring your devices are safely and efficiently brought to the market with confidence.
