Medical Device Manufacturer - Authorized Representative Mandate - EU ISO 13485 Why Do You Need a

Why Do You Need a Quality Manual

Compliance Assurance: Utilizing our template helps you maintain effective control over measurement and monitoring equipment

Compliance Assurance: Utilizing our template helps you maintain effective validation procedures for sterilisation and sterile barrier systems

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

Our QMS Planning Procedure Template helps you identify the planning needs to successfully employ and oversee the QMS

Medical Device Manufacturer - Authorized Representative Mandate - EU ISO 13485 Why Do You Need aIn 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