Allgemein

The international quality management system standard for medical devices – ISO 13485 – has been finally revised. With the...

The issue of notified bodies being under-resourced is known among the industry. The last survey of the Association of...

The Malaysian Medical Device Authority (MDA) has prepared a draft Code of Advertisement for Medical Devices. This guidance document ...

On February 18, 2016, the FDA – US Food and Drug Administration  issued a final order “Effective Date of...