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Liaison with Notified Bodies


Why should a Medical Device Manufacturer engage with a Consultancy to Liaise with Notified Bodies/Competent Authority?


Hiring an expert for liaison with notified bodies can benefit a medical device manufacturer in several ways. First, notified bodies are responsible for evaluating and certifying medical devices for compliance with regulatory requirements, such as the EU's Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR). An expert in this field will have a thorough understanding of the regulations and requirements, and will be able to guide the manufacturer through the certification process.


Second, an expert can help the manufacturer identify and address any potential issues or concerns with the device before it is submitted for certification, which can save time and resources in the long run.


Third, an expert can help the manufacturer maintain compliance with regulations after the device is certified, by providing ongoing support and guidance on any changes or updates to the regulations.


In summary, hiring an expert for liaison with notified bodies can help ensure that a medical device manufacturer's products are compliant with regulations, saving time and resources, and supporting compliance in the long-term.


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