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Notified Body and Engagement


How does a Medical Device Regulatory Affairs Consultancy help Medical Device Manufacturers in liaising with notified bodies?


Medical Device Regulatory Affairs Consultancy like Med-Di-Dia can help medical device manufacturers in several ways when it comes to liaising with notified bodies. Some of the ways include:

  1. Providing guidance and support on regulatory requirements: MDD experts have a thorough understanding of medical device regulations, such as the EU's Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), and can provide guidance and support to manufacturers in order to ensure compliance with these requirements.
  2. Assisting with the preparation of technical documentation: MDD experts can help manufacturers prepare the technical documentation required for certification, such as the technical file and the clinical evaluation report. This can ensure that the documentation is complete and accurate, and that it addresses all the relevant requirements.
  3. Representing the manufacturer during the certification process: MDD experts can act as the manufacturer's representative during the certification process, communicating with the notified body on behalf of the manufacturer, and addressing any questions or concerns that may arise.
  4. Providing ongoing support and guidance: After the device is certified, MDD experts can provide ongoing support and guidance to manufacturers to ensure that they maintain compliance with the regulations. This can include keeping manufacturers informed of any changes or updates to the regulations, and providing guidance on how to address them.
  5. Quality Management System Implementation, Auditing and Maintenance: MDD experts can help the manufacturers to implement, maintain and audit the Quality Management System as per the regulations.

In summary, an MDRA consultancy like Med-Di-Dia can help medical device manufacturers navigate the certification process and ensure compliance with regulations, by providing guidance, support, and representation during the certification process, and ongoing support and guidance after the device is certified.


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