Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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With our team’s extensive experience in regulatory affairs and Quality Management, we offer comprehensive support to create the documentation framework necessary for successful registration. Our approach focuses on providing strategic guidance and practical solutions to address regulatory requirements effectively.
We develop customized SOPs and documentation templates created to the specific needs of the client. Our team ensures that all documentation is aligned with EU medical device regulations, including the Medical Device Regulation (MDR) and relevant guidance documents.
We provide strategic guidance to optimize processes and systems for compliance with EU regulatory requirements.
Our experts conduct a thorough assessment of existing documentation and processes to identify gaps and deficiencies. We review SOPs, technical documentation, and Quality Management Systems to ensure alignment with EU regulatory standards.
Our consultants offer recommendations for process improvements, risk management strategies, and compliance measures to enhance efficiency and ensure successful registration.
Additionally, we provide trainings to ensure ongoing compliance and readiness for regulatory submission.
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.
