DescriptionImprove your sales and increase customer satisfaction with medical devices that bear the CE Mark, allowing them to be legally sold within the European Union (EU) and the European Free Trade Area (EFTA). Get a clear understanding of the European directives to ensure that your products meet designated minimum safety standards and quality levels, while minimizing liability risks associated with noncompliance. Ensure your product can move freely throughout the European Single Market.Intended for medical device manufacturers who want to export to Europe, this two-day course provides an overview of the following EU directives: Active Implantable Medical Device Directive (AIMDD), Medical Device Directive (MDD), and the In Vitro Diagnostic Device Directive (IVDD). Also covered are the requirements for safety, health, environment, and consumer protection set forth by the European medical device directives. CE Marking, EU Directives, and Guidance Documents Topics: - History, objectives, and structure of the EU directives and related directives
- The current medical device regulatory landscape in the EU
- The purpose of the medical device directives
- Meeting the new requirements for conformity assessment by product type
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