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Our comprehensive medical device registration support services are tailored to guide clients through every stage of the EU registration process. From documentation creation and regulatory evaluation to submission and authority liaison, we provide hands-on support to ensure all steps are carried out accurately and efficiently. Leveraging our expertise in both EU MDR and IVDR frameworks, we assist clients in streamlining the registration journey. Our goal is to minimize delays, enhance regulatory compliance, and support market access success for medical devices and IVDs through a strategic, quality-driven approach to registration.
One of the core elements of our medical device registration support involves creating and compiling complete, regulator-ready documentation. We help clients prepare essential records such as technical files, design dossiers, declarations of conformity, and risk management reports. Each document is developed to meet the strict format and content standards set by the EU Medical Device Regulation (MDR). Our experts also ensure consistency with ISO 13485 requirements. This structured approach eliminates gaps and supports fast-track reviews, reducing the risk of rejection or delays during the submission and approval process.
Our team conducts a thorough review of all regulatory documentation as part of our medical device registration support services. We evaluate compliance with EU MDR and IVDR, scrutinizing technical documentation, labeling, post-market surveillance, and QMS elements. The outcome includes a detailed gap assessment that identifies nonconformities, weaknesses, or inconsistencies. These insights help clients take corrective actions proactively and improve overall documentation quality. With our expert oversight, clients can feel confident that their regulatory submissions meet current EU expectations and will withstand scrutiny during reviews or audits.
As part of our full-cycle medical device registration support, we manage the end-to-end submission process. This includes preparing application packages, ensuring documentation completeness, and communicating with Notified Bodies or Competent Authorities. Our team monitors submission timelines, follows up on status updates, and responds promptly to requests for clarification or additional information. We also assist with drafting responses to regulatory feedback to resolve issues quickly. This active involvement ensures a smoother review process and improves the likelihood of first-pass approval for EU market authorization.
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.
