qmssolutions ISO Quality Management Consulting
Training in Medical Device Management
- Tel: 01-8957677
- Email:info@qmssolutions.ie
Training in Medical Device Management
Course Description
The purpose of our Medical Device training is to provide the learner with the skills and knowledge necessary to enable the learner to effectively apply the requirements of ISO13485:2003 to their place of work, given their specific roles, responsibilities and industry.
Who should attend:
The course is suitable for personnel from medical device manufacturing industries who have a working knowledge of ISO 9000. It would be of particular interest to supervisors and managers working in the following areas:
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 roles, responsibilities and training objectives. Training manuals are developed in consultation with the learner and / or client to ensure our trainings are practical in terms of the organisations needs now and into the future. Training manuals and course content are based on industry best practice, applicable legislation / regulatory requirements, FETAC criteria and international standards. As Quality Management Consultants the emphasis when developing management systems and subsequent provision of training is always customer / client focused.
Course Programme
Topics covered within our medical devices management training include:
- Course Introduction
- Quality system regulations
- ISO 13485:2003
- EU Regulatory Requirements – CE Marking
- QSIT, the FDA approach to auditing medical device companies
- Examples of FDA enforcement action
- The purpose of the internal audit
- The audit process
- Selecting the audit team
- Tools available to auditors including QSIT
- Audit preparation
- Audit performance
- Evaluating & reporting the audit.
Training Methodologies
Training methodologies include the use of case studies, sample documentation / templates, and questionnaires. All learners are supplied with training manuals and supporting process documentation. Trainings are interactive in that learners are encouraged through the use of the above resources to participate and therefore, contribute their views and opinions based on their own experience.
Course Fees
€250 development cost and €90 per participant thereafter. Minimum Daily Rates Apply.
Accreditation
All learners are awarded a Certificate of Achievement on successful completion of the course.
