October 11, 2022
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 [...]
April 12, 2022
Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The EU MDR [...]
April 5, 2022
Initiated by the World Health Organization and celebrated by all, each April 7 is recognized worldwide as world health day! This April 7 is no [...]
May 24, 2022
The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for medical device manufacturers commercializing their devices in the European Union. For manufacturers of higher-risk devices (Class IIa, Class IIb, and [...]
May 17, 2022
The short answer is, yes, it can be. MDR compliance may not have been expensive in the past, but as the regulations are changing, so is the cost to follow them. The new rules [...]
May 10, 2022
The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are two sides of the same regulatory coin in almost all aspects: both regulations seek to set up a regulatory system [...]
May 3, 2022
When one tries to publish in an international journal these days, they inevitably encounter an obstacle: researchers around the world have more than likely published thousands of papers on a similar topic, which could need [...]
April 26, 2022
A year into the EU Medical Device Regulation (MDR 2017/745), it is safe to say the implementation of the MDR has been complicated, for both manufacturers and the notified bodies. Even though the European Parliament [...]
April 19, 2022
A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices. The [...]
April 12, 2022
Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The EU MDR (2017/745) requires clinical evaluation and post-market surveillance programs to ensure [...]
April 5, 2022
Initiated by the World Health Organization and celebrated by all, each April 7 is recognized worldwide as world health day! This April 7 is no different. Each year, on this day, the World Health Organization [...]
March 29, 2022
Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer's job is not only to come up with a device that will be beneficial to the patient [...]