Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Our service focuses on hands-on support throughout the registration process, including document creation, regulatory evaluation, document submission, and follow-up. With our expertise in regulatory affairs and quality management, we ensure efficient and compliant execution of activities to facilitate successful registration.
We work closely with clients to create and compile all necessary documentation required for EU registration, including technical files, design dossiers, and regulatory submissions.
Our team ensures that all documents are prepared according to EU regulatory requirements, including compliance with the Medical Device Regulation (MDR) and relevant guidelines.
We conduct a comprehensive evaluation of documentation to ensure compliance with EU regulatory standards. Our experts review technical documentation, labeling, and quality management systems to assess conformity with regulatory requirements and identify areas for improvement.
We manage the submission process and liaise with regulatory authorities on behalf of our clients to ensure timely and accurate submission of documents. Our team monitors the progress of submissions and provides ongoing follow-up to address any queries or requests for additional information from regulatory agencies.
We also assist in coordinating responses to regulatory feedback and facilitate communication between the client and regulatory authorities to expedite the registration process.
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.
