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ISO 14971:2007 Medical Devices Risk Management Training Course
Course Category: Medical Devices Quality Management Systems (QMS)
Course Title: Medical Device Risk Management based on ISO 14971:2007
This ISO 14971:2007 is the specified standard for risk management used to demonstrate compliance with the Risk Management requirements of the Medical Devices Directive (MDD) and the In Vitro Diagnostic Device Directive (IVDD). Additionally, review of the MDD by the European Commission concluded that manufacturers did not address risk management sufficiently, hence the increased emphasis on risk requirements in the update to the MDD. The revision to ISO 14971 has also been implemented to address these requirements. This course provides a thorough introduction and interpretation of ISO 14971:2007 risk management, throughout the product lifecycle, including a summary of the latest changes to the standard.
Course Certification
Kelmac Group Certified Course
This course has been designed by leading experts to provide high quality training to professionals seeking to effectively understand ISO 14971 (Risk Management) and its implications.
Who should attend?Benefits to Your Business
- Quality Managers
- Quality Control Professionals
- Healthcare Consultants
- Medical Device Consultants
- Senior managers
- Product designers
- Regulatory affairs professionals
- Clinical affairs professionals
- Manufacturing operations personnel
- Professionals in the Medical Device Industry & Supply Chain
- The knowledge to effectively understand ISO 14971 and the principles of Risk Management
Course Pre-requisitesLearning Objectives
- Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Recommended is a basic awareness of medical devices, quality assurance, and ISO 13485.
- To understand that risk analysis is a regulatory requirement for all classes of medical device
- To understand risk management versus risk analysis
- To understand the interaction with ISO 13485:2003
- To be able to construct a basic risk management plan
- Use of the ISO 14971:2007 annexes in conducting a risk analysis
- To identify key quality management system procedures which need to link to risk management
- To understand that FMEA (Failure Mode and Effects Analysis) alone is not medical device risk analysis
- The requirements and structure of a Risk Management File
- Awareness of changes from ISO 14971:2000 to ISO 14971:2007
Course Structure
This course is a 8 hour/1 day course.
Course Start: 08:45a.m & Course Finish: 17:30p.m
A detailed course breakdown is as follows:
- Regulatory requirements for medical device risk management
- Content and interpretation of ISO 14971:2007
- Alignment of ISO 14971:2007 to ISO 13485:2003
- What is a risk management plan?
- How to conduct a risk analysis
- What is risk control?
- Requirements for a Risk to Benefit evaluation
- The risk management process within the product lifecycle
- ISO 14971:2007 - main changes from EN ISO 14971:2000
Course Assessment
The delegate is assessed based on participation and performance throughout the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course. Please note, full attendance is required during the training course.
Training Methodology
Accelerated learning is the most advanced teaching and learning method available today. It's a total system of enhancing and speeding up both the design and learning process. What makes accelerated learning so effective is that it's based on the way we naturally learn. It does this by actively involving the whole person, using physical activity, creativity, collaboration among learners, variety that appeals to all learning styles, contextual learning with real-world immersion, the creation of a positive physical, emotional, and social environment and other methods designed to get people deeply involved in their own learning.
What's Included on the course
- Comprehensive Course Manual
- Delivery by Expert (s) with real life experience
- Additional Handouts
- Digital Training Certificate of Attainment and/or Successful Completion
Further Information
Kelmac Group offer all of our Training Solutions on an In Company/In House basis. These solutions can be tailored to meet the specific needs and requirements of the client.
Our fees are very competitive and if you would like further information, please contact our office directly on +353 (61) 491224 or email info@kelmacgroup.com
