8990 Springbrook Dr. NW
Suite 210
Minneapolis MN 55443
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
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
Medical Device Single Audit Program (MDSAP) – Auditor Training
4 Days - 3.2 CTUs
- Learn to integrate the MDSAP and other regulatory requirements your ISO-13485:2016 Quality Management System
- Learn to meet the regulatory internal auditing requirement in ISO-13485:2016 clause 8.2.4.a)
- Integrate “risk-based auditing” into your internal audit program
- Learn regulatory interpretations of the ISO-13485:2016 standard such as Design Transfer, Change Control, Identification, Traceability
- Learn to classify a medical device in 5 countries
- Learn objective methods to classify non-conformances
- Learn Task Based Auditing
Process Validation for Medical Device, Pharmaceutical, and Combination Product Manufacturing
- Fully understand the regulatory requirements for process validation and their relationship to the Medical Device QSR and the Pharmaceutical cGMPs
- Gain knowledge to help manage a successful validation project
- Fully understand and successfully interpret the GHTF/SG3/N99-10:2004 Guidance on Process Validation
Understanding and Implementing ISO 13485
Use this training to jumpstart (or re-start) your ISO 13485 Implementation Project
This course is designed for participants who need to implement ISO 13485 within their organization. Participants will understand the requirements and the implications for their organization and will acquire tools that will help them:
- Fully understand and successfully interpret the ISO 13485 requirements
- Achieve the benefits that are inherent within the ISO 13485 requirements
- Proceed with their project in a timely, cost effective manner
2-Day Documentation for Medical Device
This course places documentation in its proper place as one of many tools used by organizations to assure results. People attending this course will understand and apply their newly acquired skills to determine: when a document is needed, alternatives to documentation that may achieve better results, and how to configure documentation to meet the unique needs of the situation to be managed and the people performing the task.
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.