Medical Device Manufacturer - Authorized Representative Mandate - EU ISO 13485 Management Representative: Your organization will

Management Representative: Your organization will appoint a Management Representative responsible for maintaining the Master Document List

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

ISO 13485:2016 QMS Template - Design Transfer Checklist

Expertly Designed: Our seasoned Quality Assurance and Regulatory Affairs specialists crafted these templates to ensure full compliance with ISO 9001:2015 standards

Medical Device Manufacturer - Authorized Representative Mandate - EU ISO 13485 Management Representative: Your organization willIn 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