The CE marking allows manufacturers to market medical devices in Europe, but in order to market products outside the European Union manufacturers must comply with the registration requirements and regulatory requirements required by the competent authority in each country, and each country will require the company to have a quality management system in accordance with its requirements.
So, for example, in the USA the competent authority is the FDA and will require the manufacturer, depending on the risk of the product, to prepare dossiers for FDA (510k) or a Premarket Approval (PMA), and the requirements of 21 CFR 820 for the quality management system.
In addition, each country will have specific requirements for technical product documentation and quality management system.
Azierta can assist you in preparing the documentation for product registration and the quality management system for other countries.
