Training in ISO 13485 Medical Device – Quality Management
Training in ISO 13485 Medical Device Quality Management
Course Description
QMS Solutions ISO 13485 Medical Device training is designed to provide the learner with the skills and knowledge necessary to enable the learner to effectively apply the requirements of ISO13485 to their medical device process, product and services.
Who should attend:
The course is suitable for personnel from medical device manufacturing industries who have a working knowledge of ISO 9001. It is of particular interest to supervisors and managers working in the following areas:
- Quality assurance / quality control
- Production
- R & D
- Purchasing
- Human resources
- Engineering
It will also be of interest to managers who are required to liase with notified bodies.\
Training Approach
All QMS Solutions trainings are tailored to the specific training needs of the learner given their specific role, responsibility, authorityand training objectives. Training manuals are developed in consultation with the learner and / or client to ensure our trainings are practical, reflect your work environment and add real value in terms of learner outcomes. Training manuals and course content are based on industry best practice, applicable legislation / regulatory requirements and international ISO standards (ISO 13485:2016, EU 2017/745 MDR and EU 2017/746).
Trainings are delivered by Qualified trainers and experienced quality management consultants.
Course Programme
Topics covered within our medical devices management training include:
- Introduction to ISO 13485:2016
- Overview of the Legal and Standards framework for quality management
- CE and CFR approval
- MDSAP – Medical Device Single Audit Program
- Structure and content of the standard
- Scope of the standard and application
- Management commitment and leadership
- Risk management
- ISO 14971 Medical Device Risk Management
- Resource management
- Requirements for products, process or services
- Design and development
- Supplier management
- Process control
- Performance evaluation
- Post market surveillance
- Post market vigilance
- Control of non-conformities
- Internal audit
- Management review
Training Methodologies
All learners are supplied with training manuals and supporting resources. Trainings are interactive whereby learners are encouraged using resources to participate and contribute their views and experience throughout the training. Training methodologies include the use of case studies, sample documentation / templates, and questionnaires.
Trainings may be delivered online via MS Teams or on-site at the leaners place of work.
Course Duration
We offer one and two day introductory trainings to Quality Management and a five-day comprehensive training program in Quality Management. Our quality management training is applicable to all sectors.
Course Fees
1 day training in ISO 13485 training is charged @ €750 and €120 per participant thereafter. Minimum Daily Rates Apply.
Certification
All learners are awarded a Certificate of Achievement on successful completion of the course.
