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Understanding and Implementing the Medical Device Directive

(www.complianceonline.com)

Most medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives.

Tags

  • Medical Device Directive, documentation, medical devices, regulatory approach, Quality Management System (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MDD Annex X)

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