Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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We offer comprehensive consulting services for Medical Devices and IVDs EU Registration, focusing on implementation and continuous improvement to ensure alignment with international standards. Our service encompasses strategic guidance and practical support to streamline the registration process and enhance compliance with regulatory requirements, enabling companies to navigate the complexities of European market access effectively.
We conduct a thorough assessment of the company’s existing regulatory practices and processes related to medical device registration. By doing this, we evaluate the alignment with relevant European regulations such as Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). By the end, the activities will identify GAPs and areas for improvement in regulatory compliance and documentation.
Our team collaborates with the client to develop a customized strategy for medical device registration in the European market. We define clear objectives, milestones, and action plans to guide the implementation process, establishing robust quality management and documentation practices to support regulatory requirements.
Our experts will implement mechanisms for ongoing monitoring, evaluation, and improvement of the registration process. Through periodic reviews and audits, we assess compliance status and identify opportunities for optimization.
Additionally, we provide training and support to empower internal teams in maintaining regulatory compliance and driving continuous improvement efforts.
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.
