EU Medical Device Regulation (Live Online Training)

A successful implementation will demonstrate a company’s ability to supply medical devices and related services to customers that comply with regulatory requirements. ISO 13485 is not just product focused, but it focuses instead on the processes used to develop medical devices. Keep in mind that you also need to comply with all relevant products and service oriented technical standards and regulations in this area of expertise.
▪This regulatory frame work defines the expectations of European Commission, as well as medical device manufacturers, notified bodies and member state competent authorities. The regulation published on 5 May 2017 will came into force from 26 May 2021
▪This two-day training course introduces you to the key changes from the European Medical Device Directive (MDD) to the new European Medical Device Regulation (MDR). All medical devices and identified devices without a medical purpose will need to undergo a conformity assessment procedure based on the new MDR requirements, in order to place devices on the European Union market. The course will give a general guideline of how to approach application of the new MDR, and will highlight the differences to the MDD that will affect all manufacturers.