Medical Device Manufacturer - Authorized Representative Mandate - EU ISO 13485 Compliance Assurance: Utilizing our template

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

ISO 13485:2016 QMS Template Bundle

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

Enhance Equipment Reliability: Proactively identify and mitigate risks to ensure equipment operates effectively and safely

Medical Device Manufacturer - Authorized Representative Mandate - EU ISO 13485 Compliance Assurance: Utilizing our 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