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An Engineer Takes on CE Marks and European Commercialization

Medical device companies have one primary goal: to develop, manufacture and market a medical device that addresses an unmet market need. While it’s a common goal, the medical device regulatory approval process can be confusing for design and development engineers. They may hear terms such as “safety agency,” “CE mark,” “Notified body,” “510K” and “PMA” tossed around by quality and regulatory professionals. Although these terms are likely somewhat familiar, their true meanings and proper application are not always clear to many of us who are part of the development process.


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Stratos Product Development LLC

http://www.stratos.com
E: info@stratos.com
T 2064481388
   206/448-1388
F: 206/448-7830

Address
2401 Elliott Ave, 5th Floor, World Trade Center North, Seattle, Washington, 98121, United States
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Stratos Product Development LLC

http://www.stratos.com
E: info@stratos.com
T 2064481388
   206/448-1388
F: 206/448-7830

Address
2401 Elliott Ave, 5th Floor, World Trade Center North, Seattle, Washington, 98121, United States
View map

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