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Look here for Industry updates and technical tutorials written by the CiteMed staff.  All things Medical Device Regulation are covered in our publications.

IVDR FAQ and Best Practices for The Vigilance of In Vitro Diagnostic Medical Devices

By |November 15th, 2022|Categories: CiteMed-Staff, EU MDR, In the press, Latest Publications, On-going research|Tags: , , |

The purpose of vigilance is to protect the health and safety of patients, healthcare professionals, and other users by reducing the probability of reoccurring serious incidents related to in vitro diagnostic medical devices. For that [...]

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Market Surveillance of Medical Devices Under the EU MDR

By |November 8th, 2022|Categories: CiteMed-Staff, EU MDR, In the press, Latest Publications, Post Market Surveillance|

The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed on the market. In these activities, the national regulatory authorities put measures [...]

The Post-Market Surveillance Document: Which Ones Do you Need?

By |November 1st, 2022|Categories: CiteMed-Staff, EU MDR, In the press, Latest Publications, Post Market Surveillance|

It's not enough to make a device and put it on the market—you must know how people use your product. Therefore, the post-market surveillance must cover all devices that have been placed on the market, [...]

Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices

By |October 25th, 2022|Categories: CiteMed-Staff, EU MDR, In the press, Latest Publications, Post Market Surveillance|

In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by the European Parliament and Council, came into force. The regulation forms the core of European market surveillance law and will [...]

In Vitro Diagnostic Devices Regulation (IVDR) and How It Relates to CE markings

By |October 18th, 2022|Categories: CiteMed-Staff, EU MDR, In the press, Latest Publications|

CE marking indicates compliance with an EU directive so that you can market your products in the EU.   It's that simple.   CE marking is a voluntary conformity assessment procedure, but it is a [...]

Medical Device Reporting (MDR): How to Report Problems to the FDA

By |October 11th, 2022|Categories: CiteMed-Staff, EU MDR, In the press, Latest Publications|

Even though every medical device manufacturer does their utmost to ensure their medical devices are safe and efficient, adverse events still happen. Off-label use, installation/service issues, lack of training, and many other causes can lead [...]

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