ISO 13485:2016 & Medical Device Training
The medical device industry is extremely complicated and competitive. We offer a number of courses to train auditors and staff on the standards of ISO 9001, ISO 13485, and more!
EU 2017/745 Medical Device Regulations
EU 2017/745 Medical Device Regulations
3 Days - 2.4 CTUs
- Understand the structure of the new MDR
- Recognize the significant changes compared to MDD
- Know the key aspects of requirements for CE Marking
- Examine the changes in device definitions and MDR terminology
- Analyze the significant aspects affecting the device manufacturer
- Interpret the range of technical documentation required
- Discuss the key changes impacting conformity assessment
- Describe the transition timeframes, current position
MDSAP
Process Validation
Understanding and Implementing
Documentation
Please note that participating in this or any DEKRA trainings should not in any way be linked to (the outcome of) any certification activities carried out by other DEKRA entities.