Author archive for Katarzyna Mizerska

Health Canada prepares to start in 2017 the process of adopting the Medical Device Single Audit Program (MDSAP) in...

The Malaysian government exempted all types of Class A (lowest-risk) devices from conformity assessment requirements to make it easier...

From April 17 – 20, 2016, the spring CMEF 2016 in Shanghai, China, will take place. Mr Klaus-Dieter Ziel,...

We are pleased to inform that MEDCERT has successfully passed its annual surveillance audit performed by the German Authority...

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...