International: New ISO 134850Read more
The international quality management system standard for medical devices – ISO 13485 – has been finally revised. With the...
EU: Notified Bodies resources problemsRead more
The issue of notified bodies being under-resourced is known among the industry. The last survey of the Association of...
Malaysia: Code on Advertisement for Medical DevicesRead more
The Malaysian Medical Device Authority (MDA) has prepared a draft Code of Advertisement for Medical Devices. This guidance document ...
USA: PMAs obligatory for Metal-On-Metal HipsRead more
On February 18, 2016, the FDA – US Food and Drug Administration issued a final order “Effective Date of...
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