MDR is new legislation and for initial approvals, a complete submission with all the relevant Technical Documentation included is required even if the device was previously certified under the MDD or AIMDD A subset of the information contained in the technical documentation is used by the manufacturer when submitting the device to the NB for pre-market or post-market conformity assessment activities.
The technical documentation should be structured and presented, in such a way, as to facilitate its review and assessment by the NB MAVEN PROFCON SERVICES LLP is an India based regulatory consultancy for various certifications of Medical Devices. We strive to foster innovative services that will contribute substantially to our customer’s success.
We provide consultative technical and regulatory expertise. Our team is empowered to build trust at every step. We work closely with our clients to ensure all communications and regulatory requirements are transparent and clearly addressed in a timely manner.
We at Maven, have various technical experts to help your curb your regulatory issues and help you emerge in the EU Market during this transition period and survive the stringent steps taken up by the EU commission for marketing medical devices in European countries. Contact us today!
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