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!
ISO 13485:2016 Certified Lead Auditor Training
Exemplar Global Competency Units MD, AU, TL
- Requirements of ISO 13485, ISO 9001, and 21 CFR 820
- How to apply the standards in the medical device sector
- Methods for planning and conducting an audit
- Audit skills and behaviors necessary for an effective, efficient management system audit
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
MDD to MDR Transition
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.