A Basic Guide to the Evaluation of Standards
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 ...
Fachpublikationen: Medizintechnik
Compendium: EU Regulations on medical devices and IVDs
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 US FDA PMA filing and approval experience
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 ...
Regulatory control of medical device circulation in the Russian Federation
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 ...