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ISO 13485 Lead Implementer training prepares you to assist an organisation in establishing, implementing, managing, and maintaining an ISO 13485-based Medical Devices Quality Management System (MDQMS). You will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems during this training course, and you will be able to improve an organisation’s overall performance by consistently providing safe and qualitative medical devices.
Fees
€1,010.00 per student exc. VAT
COURSE OUTLINES
Course Agenda
Duration: Can be taken at your own pace.
Day 1: Introduction to ISO 13485 and initiation of a MDQMS
- Course objectives and structure
- Standard and regulatory framework
- Medical Devices Quality Management System (MDQMS)
- Fundamental principles of quality and medical devices
- Initiating the MDQMS implementation
Day 2 Plan the implementation of the MDQMS
- Understanding the organisation and clarifying the quality objectives
- Analysis of the existing management system
- Leadership and approval of the MDQMS project
- MDQMS scope
- Quality Policy
- Definition of the organisational structure
Day 3 Implementation of a MDQMS
- Definition of the document management process
- Design of controls and drafting procedures
- Communication plan
- Training and awareness plan
- Product Realisation
- Operations Management
Day 4 MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit
- Monitoring, measurement, analysis and evaluation
- Internal audit
- Management review
- Treatment of problems and non-conformities
- Improvement
- Preparing for the certification audit
- Competence and evaluation of implementers
- Closing the training
Day 5 Certification Exam (3 Hours)
The “PECB Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:
- Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
- Domain 2: Medical Devices Quality Management System (MDQMS)
- Domain 3: Planning a MDQMS implementation based on ISO 13485
- Domain 4: Implementing a MDQMS based on ISO 13485
- Domain 5: Performance evaluation, monitoring and measurement of a MDQMS based on ISO 13485
- Domain 6: Continual improvement of a MDQMS based on ISO 13485
- Domain 7: Preparing for a MDQMS certification audit
COURSE DETAILS
Duration: Up to 6 months
Starts: Upon Registration
Ends: After Examination
You'll be signed up to our PECB platform KATE where you will have access to all training procedures.
Certification fees are included on the exam price
- Training material containing over 450 pages of information and practical examples will be distributed.
- In case of exam failure, you can retake the exam within 12 months for free.
The course is eligible for funding on the Get Qualified Scheme
PREREQUISITES
A fundamental understanding of ISO 50001 and comprehensive knowledge of implementation principles.
FEES & FUNDING
Through the Get Qualified Scheme, students benefit from tax credits of up to 70% of their course fees after successful completion. Our team can assist you with applying for the Get Qualified scheme when undergoing training at the NOUV Academy.
Businesses seeking to train their staff can benefit from the Investing in Skills Scheme, a government incentive designed to provide support to companies to increase the productivity and adaptability of individuals that are active in the Maltese labour market. Our team will assist you in accessing applicable schemes when enrolling your staff in training courses through the NOUV Academy.