Medical Device Manufacturer - Authorized Representative Mandate - EUIn accordance with Article 11 of European Medical Device Regulation 2017 745 manufacturers who are based in 3rd countries (countries not based within an EU member country) are required to have an Authorised Representative. The Regulation states that there must be a mandate in place between the Manufacturer and the Authorized Representative. The Regulation provides the following information as a minimum on what the Mandate needs to contain: 2. The

Infrastructure

ISO 13485:2016 QMS Template - Risk Identification Analysis & Control - Software (QMS

The declaration of conformity is a statement made and signed by the legal manufacturer that they have met all the regulatory requirements stated within the regulation

including employee inductions

ISO 13485:2016 QMS Template - Management Review Meeting Minutes (QMS

A CAPA procedure is essential for detailing the steps to raise and implement corrective and preventative actions when you identify a non-conformance in your Quality Management System

this tool ensures your organization effectively manages training and qualification processes

up-to-date

workspaces

Maintaining control of records is crucial for demonstrating compliance with ISO 13485 requirements

Enhances quality assurance and regulatory compliance across your organization

What is a Management Responsibilities Procedure