If you manufacture or sell medical devices in Europe, then you already know that the route for conformity for CE markings are changing. But, do you have a full understanding of the impacts these changes will have on your products, supply chain, and business?
Conformity with the EU MDR, (EU) 2017/745, brings many challenges to all medical device manufacturers and many of their economic operators. At MDR Consultants, we offer an in-depth EU MDR training course that is designed to help manufacturers and their teams prepare for these challenges so that they can transition their quality management systems and products effortlessly to the requirements of the EU MDR regulation.
Our MDR training course is ideal for those who do not have a full understanding of all the changes that this regulation brings and/or for those who wish to refresh their knowledge. Our EU MDR GAP assessment course has been developed by leading industry experts to assist medical device professionals to understand the requirements of the regulation. This course will not only teach the participants all the changes implemented by the new regulation but it will also teach them how to effectively implement those new requirements into their quality management systems.
Seasoned MDR Trainers
At MDR Consultants, we have expert trainers who will take you through the relevant provisions of the EU MDR Regulation (EU) 2017/745, from an industry perspective and also from a notified body perspective. This means that you will benefit immensely from the understanding of what all sides are looking for with regards to conforming to the EU MDR(EU) 2017/745.
Our EU MDR auditor training course offers you and yourr staff a practical understanding of the EU MDR. This training course allows adequate time for discussion and learning exercises after every module designed to deepen the understanding and applicability of the provisions of the regulation. After the training, your team will feel confident and comfortable performing their own gap analysis on their systems and designing remediation strategies to achieve or mantain not only CE marking but also full compliance with the provisions of the regulation through implementation of requirements into their quality management systems.
Who Should Attend the MDR Training?
Our EU MDR training is ideal for all employees involved in any aspect of the medical device quality and regulatory aspects of their organization’s quality management system as well as all upper management. A basic understanding of the present European Medical Devices Directive 93/42/EEC is recommended. However, it is not required. Our EU MDR training course will be valuable for the following professionals:
EU MDR Training with Seasoned Medical Device Consultants
Our MDR training is valuable not only for the industry professionals belonging to medical device manufacturers as mentioned above but also to the relevant industry professionals of any of the economic operators of those manufacturers. To include but not limited to contract manufacturers, importers, and distributors. Our EU MDR auditor training is conducted by senior regulatory consultants who spend their time working with customers on EU MDR conformance. They are conversant with the needs of the medical device industry and understand all the practical aspects of meeting the relevant provisions of the regulation. Contact us today for detailed information or a proposal for intensive EU MDR training for you and your staff.