European Union Medical Device Regulation – EU MDRNSF International, Pharmaceutical Services
European Union Medical Device Regulation – EU MDR
In 2017, the Medical Device Regulation (EU MDR) 2017/745 was published, introducing major changes to the previous Medical Device Directive (MDD). Significant changes include device classification, requirements for technical documentation, and clinical evidence, to name a few. To comply with the new EU MDR, medical device manufacturers must plan carefully to ensure the new requirements are fully understood and they identify appropriate resources for full implementation. This on-line computer-based learning course provides comprehensive instruction on the EU MDR. It walks students through every aspect of the regulation and identifying key topics and changes, including the new roles associated with EU MDR; standard requirements that must be met by all manufacturers regardless of class; and the requirements for conformity assessments. The module also provides pre- and post-market requirements of conformity assessment.
Outcome / Qualification etc.
By completing/passing this course, you will attain the certificate Medical Device Certificate
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.
NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...
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