Aug 23 - 4:54
All medical device manufacturers should be aware that the last CE certificate renewal deadline expires later this month. Those who miss it could face regulatory issues, delays, and additional expenses. CE Certificate...
Aug 22 - 4:39
Designation According to the notice published by the Medical Devices Division of CDSCO, the regulating authority registered six notified bodies, authorizing them to perform medical device manufacturing site audits, the...
Aug 20 - 6:14
The adoption of Medical Device Regulation is a new step towards the improvement of the medical device regulatory framework. Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical...
Jul 18 - 6:33
RBM is essential in clinical trials, where sponsors monitor clinical investigations and determine any problems or risks involved with their studies that could impact participants or the general public. The FDA wants to...
Jul 17 - 4:36
International Medical Device Regulators Forum, a voluntary group of medical device regulators, emphasizes the importance of the terminology issue and submits a proposal to amend the existing system. Focus on...
