What is 510k summary?

August 12th, 2021|0 Comments

What is 510k summary? The 510(k) summary is an abstract of the details related to the proposed device included in the 510(k) file and the supporting [...]

Attributes of Biological Evaluation

June 22nd, 2021|0 Comments

B Biological Evaluation is estimation of biological responses of the product to ensure safety and efficacy with patient and user. Biological Evaluation of Medical Devices is [...]

  • Law

EU 2017/745 and EU Representative

July 2nd, 2015|0 Comments

Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s, when an [...]

Actor Registration

July 2nd, 2015|0 Comments

All economic operators  in the European territory  and non-EU manufacturers, authorized representatives, system/procedure pack producers, and importers [...]


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