nsaaudit.blogg.se - En iso 13485 permission number

This certification is then maintained through regularly scheduled annual surveillance audits by the registrar, with re-certification of the Medical Devices Quality Management System performed on a tri-annual basis. 2012: EN ISO 13485 is revised so that it harmonizes with the three European directives associated with the medical sector: 93/42/EEC (medical devices), 98/79/EC (in vitro diagnostic medical devices), and 90/385/EEC (active implantable medical devices).

ISO 13485 certification (also known as “registration”) is a third-party audit performed by a certification body such as PECB MS who, upon verification that an organization is in compliance with the requirements of ISO 13485, will issue an ISO 13485 certificate.

Boost of loyal customers and potential customers.

Lower skepticism and increased confidence for end-customer Any use, including reproduction requires our written permission.

Increased likelihood of meeting Customer Requirementsīenefits of ISO 13485 certification to your customers:.

Proactive error detection and prevention.

Assistance in monitoring supply chain effectiveness.

ISO 13485 Medical Devices Quality Management System (QMS) is very close to the Food and Drug Administration’s (FDA) QSR standards.

Improved legal and regulatory or contractual requirements compliance.Benefits of ISO 13485 certification to your company: