On May 25th 2021, the Medical Devices Regulation (EU) 2017/745) will substitute the Medical Devices Directive (93/42/EEC) as the new regulation that defines the requirements that the medical device manufacturers must satisfy in order to place medical devices in the European Union market. As a result, every medical device manufacturer must consider the impact of these regulatory changes not only on their quality management system but also on their activities and business objectives. This is why MDR QMS training courses are essential for all medical device manufacturers as well as their business partners. Specially those belonging to their supply chain.
This change brings with it an array of new requirements including but not limited to more specificity related to the inspection of technical documentation including those related to clinical evaluation, post-production clinical follow-ups, and traceability of medical devices through the supply chain. It also brings many changes related to risk management that shall be implemented throughout the quality management system. To comply with the EU-MDR, manufacturers need to plan and implement a systematic update of the quality management system affected processes that should be based on understanding each required output. Only by implementing a comprehensive system approach review and update will manufacturers ensure not only that their system is conformant to the new requirements but that this status can be mantained over time.
Our MDD to MDR transition training course introduces participants to the expected changes they will find when they transition their QMS from the MDD or European Medical Device Directive to the new MDR or European Medical Device Regulation. In order to place a medical device in the European Union market or to continue to place a medical device on that market, all medical devices will have to undergo a revised conformity assessment procedure based on the new set of MDR requirements. Our training course gives its participants detail guideliness for the review and implementation of the new requirements into their quality management systems. This detail approach will ensure that the implementation processes is successful not only in producing the desired process outputs but will also ensure conformity to all applicable requirements.
How Will You Benefits From Our Training Course?
Upon completion of this transition course, participants will be able to:
Our MDR transition training is ideal for the following professionals:
Professional MDD to MDR Training Course
Our MDD to MDR training course is designed to introduce to all the medical device manufacturers and other partners in the supply chain to the changes of the regulatory requirements for CE marking after the publication of the novel Medical Devices Regulation (MDR). Our gap analysis between MDD and MDR course provides participants with the knowledge and expertise to help their companies in preparing for a smooth and successful transition. Contact us today to get detailed information about our MDD to MDR transition training course.