An Engineer Takes on CE Marks, FDA Approvals and Global Regulatory Processes

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A series of articles via MDDI online form 2012 on provide simple summary of regulatory approval process across various markets:

An Engineer Takes on CE Marks and European Commercialization .

An Engineer Takes on FDA Clearance and Approval

An Engineer Takes on Global Regulator Processes: Asia, Latin America, and More

Though the regulatory processes keep evolving, these articles do summarize the device classification and requirements fairly well for developers.

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