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 streamline execution of the activities related to the process of registering medical devices in the EU by handling key activities such as document creation, regulatory management, and project coordination. With our expertise, clients can face the complexities of EU registration efficiently and ensure compliance with regulatory standards.
Developing comprehensive documentation, including technical files, quality management system (QMS) records, risk assessments, and validation reports, tailored to meet EU regulatory requirements. Ensuring all documents are accurately prepared, properly formatted, and contain the necessary information to support the registration process.
Serving as the primary liaison between the client and regulatory authorities, facilitating communication, submitting necessary documentation, and addressing inquiries or requests for additional information. Managing regulatory timelines to ensure timely submission and approval of registration applications, while proactively addressing any regulatory challenges or issues that may arise.
Coordinating all aspects of the registration process, including task assignment, scheduling, resource allocation, and progress tracking, to ensure execution and completion of registration activities. Implementing project management methodologies to mitigate risks, resolve issues promptly, and optimize efficiency throughout 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.
