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Compliance with the ISO 13485 standard is essential for medical device manufacturers in order to provide medical devices and related services that consistently meet the customer and regulatory requirements. General Requirements EU Declaration of Conformity This is a formal document that officially certifies that your product fulfils the essential requirements needed to meet the applicable CE directives.
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SharePoint Quality Management System for Medical devices. For more information on how ISO 13485 relates to the CE marking, see: How to use ISO 13485 to get your devices approved for CE marking. For example, certain government bodies might issue requirements for ISO 13485 certification similarly, customers may require that their clients get certified to meet their specific needs. Do i need to certify to iso 13485?Ĭertification isn't a requirement of ISO 13485, but it can be necessary, depending on the context. The transition period for device manufacturers across the countries that recognize the standard to update their QMS to comply with requirements under the third edition, ISO 13485:2016, is set to last until February 2019 after which the 2003 version will be withdrawn. Upskill employees and document any training. ISO 13485:2016 has new standards for quality throughout the design and development process. Controls and quality measures in design and development. Click here for a full course outline (PDF). Risk-based thinking is a central principle of recent ISO updates. Regulatory Compliance Associates Inc., 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158. ISO 13485:2016 Quality Management System (QMS) requirements for medical devices. Here's what you need to know about the new ISO 13485:2016 Emphasis on a risk-based approach.
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