Checklists for MDR and IVDR Compliance
Handling the requirements of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) can be complex and demanding. To simplify this process, we have compiled a set of structured checklists designed to assist manufacturers in achieving and maintaining compliance. These checklists provide practical guidance across various regulatory areas, ensuring a systematic approach to meeting obligations.
Each checklist addresses specific aspects of compliance, from technical documentation and risk management to post-market surveillance and collaboration with Notified Bodies. Whether you are at the initial stages of preparation or looking to refine your existing processes, these resources can support you in aligning with MDR and IVDR requirements efficiently.
Checklists serve as tools to streamline compliance process, providing guidance and ensuring no critical steps are overlooked. These tools help ensure alignment with regulatory requirements, improve process efficiency, and reduce the likelihood of errors or omissions.
Our checklists can be used for tracking progress, maintaining consistency, and simplifying complex processes, making them useful for both initial compliance efforts and ongoing regulatory maintenance under MDR and IVDR frameworks.
