Notified Bodies an overview:



A Notified Body is a third-party organization that has been approved by an EU member state to judge whether manufacturers adhere to the relevant legislation. With such a crucial role, choosing a Notified Body and your partnership’s working relationship are crucial to getting your CE marking. As CE marking medical device consultant, we know the criticality of selecting the Notified body and hence we work with right notified bodies to get the… Continue

A FDA 510k clearance or premarket submission demonstrates that the device which is marketed is safe and effective as predicate. The FDA 510k process is necessary to enter into the US market / or to sell your device in the US market. The FDA is responsible for authoring and enforcing the medical device quality system regulations (QSR), found in 21 CFR Part 820 of the Code of Federal Regulations. The FDA 510 k clearance process is the most common pre-market pathway for medical device companies.… Continue

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CAPA is acronym of Corrective Action and Preventive Action. The CAPA process is one of the center cycles that exist inside the quality arrangement of every medical device organization.

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