{"id":260,"date":"2020-10-26T09:59:48","date_gmt":"2020-10-26T08:59:48","guid":{"rendered":"https:\/\/www.excecert.it\/eng\/?page_id=260"},"modified":"2024-10-07T12:45:57","modified_gmt":"2024-10-07T10:45:57","slug":"iso-13485-medical-devices","status":"publish","type":"page","link":"https:\/\/www.excecert.it\/eng\/iso-13485-medical-devices\/","title":{"rendered":"ISO 13485 – MEDICAL DEVICES"},"content":{"rendered":"

ISO 13485 CERTIFICATION FOR MEDICAL DEVICE MANUFACTURERS<\/h3>\n
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\"iso-13485\"<\/a><\/p>\n

What is ISO 13485 certification \"Medical devices - Quality management systems - Requirements for regulatory purposes\"?<\/h2>\n

ISO 13485 Certification defines a specific quality management system standard for companies operating in the biomedical sector and specifies requirements for quality management systems that enable an organisation to demonstrate the ability to provide medical devices and related services that comply with customer requirements and regulatory requirements applicable to such medical devices.<\/p>\n

Market access for medical devices is particularly constrained. Compliance with ISO 13485 is often required by national legislation as part of the approval and marketing process for devices. For countries belonging to the European Union, the application of ISO 13485, recognised as a \"harmonised standard\" for the Directives concerning medical devices (Medical Devices Directive 93\/42\/EEC, In Vitro Diagnostic Devices Directive 98\/79\/EC, Active Implantable Medical Devices 90\/385\/EEC), allows some of the essential requirements of these Directives to be met and is often also required by third countries in order to meet the mandatory requirements for placing medical devices on the market.<\/p>\n

ISO 13485 certification can be perfectly integrated with quality certification according to UNI EN ISO 9001<\/a>.<\/p>\n

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Please note that the quality management system requirements specified in this international standard are complementary to the technical requirements for the product required to meet applicable regulatory and customer requirements for safety and performance.<\/p>\n

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Who is interested in these certifications?<\/h2>\n

From design to product distribution, through manufacture and installation, all companies in the medical sector can implement a quality management system based on the ISO 13485 standard.<\/p>\n

ISO 13485 certification applies to manufacturers and distributors of medical devices, as well as their suppliers (and subsuppliers), regardless of their size or the type of device involved, it also applies to companies that currently manufacture medical devices under third party brands, but wish to start marketing the devices under their own name in the European Union markets.<\/p>\n

For example, Canada requires medical device manufacturers who market their products in Canada to be ISO 13485 certified.<\/em><\/p>\n

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ADVANTAGES<\/h2>\n

Certification brings numerous advantages:<\/p>\n