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 GmbH offers comprehensive consulting services for Medical Devices and IVDs EU Registration, guiding pharmaceutical companies through the complex process of registering medical devices in compliance with EU regulations. Our experienced team provides strategic guidance and practical support to streamline the registration process and ensure timely approval.
We customize regulatory strategies based on the unique characteristics of each medical device, considering factors such as intended use, classification, and risk profile. Our team outlines a clear roadmap for achieving EU registration, identifying key milestones, timelines, and regulatory requirements to ensure a smooth and efficient process.
Our experts compile comprehensive technical files containing detailed information on the design, development, and manufacturing of medical devices, ensuring compliance with EU directives and standards. We assist in the preparation of design dossiers, documenting the design, development, and performance characteristics of the device to support regulatory approval. We help establish and document robust quality management systems (QMS) in accordance with ISO 13485 requirements, ensuring that all aspects of device design, manufacturing, and post-market surveillance are adequately controlled and documented.
Our team serves as a liaison between clients and
regulatory authorities, facilitating communication and ensuring that all submission requirements are met. We prepare and compile all necessary documentation for submission to regulatory authorities, including application forms, technical files, design dossiers, and supporting evidence of compliance. We manage the submission process to ensure that all documents are submitted within the required timelines, minimizing delays and expediting the review and approval 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.
