The Journal of Medical Device Regulation is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device and IVD industries. The Journal delivers in-depth regulatory affairs review and discussion articles by ...
The Journal of Medical Device Regulation is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device and IVD industries. The Journal delivers in-depth regulatory affairs review and discussion articles by ...
Medical device manufacturers apply a wide range of standards across their operations, Quality Management Systems and to products or technology. In the latter, a company typically uses numerous standards to demonstrate fulfilment of product specifications, conformity with European regulations or specified requirements (notably, design inputs). This ...
The topics covered in this compendium are: A Competent Authority perspective on the new European medical device and in vitro diagnostic legislation The challenges in implementing the new European medical device and IVD Regulations Economic Operators in the new European Regulations on medical devices and in ...
The regulatory authority in Russia, Roszdravnadzor, has authored an article on the issues surrounding market access of medical devices in the Russian Federation, both at a national level and within the Eurasian Economic Union. The article summarises the two systems for medical device and IVD registration that currently exist, including ...
This three-part publication examines various aspects of the US Food and Drug Administration (FDA) premarket approval application (PMA) process, which is the regulatory pathway for the introduction of Class III medical devices into commercial distribution in the USA. Part one is devoted to performing a descriptive and statistical analysis of the ...