This step is the crucial phase of medical device development, where the hard work culminates in the preparation for market launch and commercialisation! 🚀
📂 To complete the technical documentation for most Class I devices, manufacturers must do the following:
✅ Register with Competent Authorities and EUDAMED
✅ Issue the Declaration of Conformity
✅ Begin marketing activities
⚠️ For higher-risk devices, the process includes submitting technical documentation to a Notified Body for conformity assessment.
👍 After a successful conformity assessment and certification, the product can finally be distributed and marketed.
At BiTrial, we simplify regulatory processes by supporting everything from technical documentation to conformity assessments, ensuring your medical device is compliant and launch-ready. Our expert team is here to guide you every step of the way, tailoring solutions to your unique needs.
Contact us for more information!