ISO 13485:2016 & Medical Device Training

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 Directive (MDD) to Medical Device Regulation (MDR) Transition

1 Day - 0.8 CTUs

• Gain an overview of the structure of the new MDR
• Be familiar with key changes in the requirements for CE Marking
• Be familiar with changes in device definitions and MDR terminology
• Recognize significant aspects affecting the device manufacturer
• Know the key changes impacting conformity assessment
• Be familiar with the transition timeframes, recently modified

Medical Device Single Audit Program (MDSAP) – Auditor Training

4 Days - 3.2 CTUs

• Learn to integrate the MDSAP and other regulatory requirements your ISO-13468:2016 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.