Do I need a full validation of QPack, or is Orcanos COC is enough?

Rami.Azulay November 11th, 2014 Posted by Rami Azulay( ) 21 CFR Part 11, 510(k), CE Marking, Notified Bodies, Pre Market Approval (PMA), QPack Validation

What is COC: Type Approval or Certificate of Conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements.

Orcanos provides this certification for its customers, but the question whether its instead of QPack validation, well, in some places it is enough, for example in Europe (CE), and in some places its not, such as in US, FDA, where the medical device manufacturer must do a full validation of any IT software he uses, based on the intended use.

You need to check with your regulatory consultant about it.


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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