Medical Device Manufacturer - Authorized Representative Mandate - EU ISO 13485 Quality Control Procedures This template

Quality Control Procedures This template ensures that the Rework Procedure is relevant to your organization

Involving top management in the QMS promotes a quality culture and ensures effective system operation

Maintenance: Guaranteeing resources are maintained to ensure continuing fitness for purpose

or to share feedback

The standard also requires documented procedures for your feedback process

Medical Device Manufacturer - Authorized Representative Mandate - EU ISO 13485 Quality Control Procedures This templateIn 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