ISO 13485 Medical Devices Quality Management System (MDQMS) - Training Courses
Lead Implementer Training
ISO 13485 Medical Devices Quality Management System (MDQMS) - Training Courses
Why should you attend?
ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.
After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a "PECB Certified ISO 13485 Lead Implementer" credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.
Who Should Attend?
- Managers or consultants involved in Medical Devices Quality Management
- Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
- Individuals responsible for maintaining conformance with MDQMS requirements
- MDQMS team members
COURSE AGENDA
DURATION: 5 Days
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 a MDQMS
- Understanding the organization 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 organizational 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 Realization
- 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
Learning Objectives
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
- Learn how to interpret the ISO 13485 requirements in the specific context of an organization
- Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
- Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices
EXAMINATION
The PECB certified ISO 13485 Lead Implementer Training Course exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competency domains:
1
Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
2
Domain 2: Medical Devices Quality Management System (MDQMS)
3
Domain 3: Planning a MDQMS implementation based on ISO 13485
4
Domain 4: Implementing a MDQMS based on ISO 13485
5
Domain 5: Performance evaluation, monitoring and measurement of a MDQMS based on ISO 13485
6
Domain 6: Continual improvement of a MDQMS based on ISO 13485
7
Domain 7: Preparing for a MDQMS certification audit
CERTIFICATION
Upon the successful completion of the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential.
Credentials
PECB Certified ISO 13485 Provisional Implementer
PECB Certified ISO 13485 Implementer
PECB Certified ISO 13485 Lead Implementer
PECB Certified ISO 13485 Senior Lead Implementer
PECB Certified ISO 13485 Master
Exam
PECB Certified ISO 13485 Lead Implementer exam or equivalent
PECB Certified ISO 13485 Lead Implementer exam or equivalent
PECB Certified ISO 13485 Lead Implementer exam or equivalent
PECB Certified ISO 13485 Lead Implementer exam or equivalent
ISO 13485 Lead Implementer + ISO 13485 Lead Auditor (4 additional foundation exams)
Professional Experience
None
Two years: One year of work experience in Medical Devices Quality Management
Five years: Two years of work experience in Medical Devices Quality Management
Ten years: Seven years of work experience in Medical Devices Quality Management
Fifteen years: Ten years of work experience in Medical Devices Quality Management
SOMS Project Experience
None
Project activities: a total of 200 hours
Project activities: a total of 300 hours
Project activities: a total of 1,000 hours
Audit activities: 700 hours Project activities: 700 hours
Other Requirements
Signing the PECB code of ethics
Signing the PECB code of ethics
Signing the PECB code of ethics
Signing the PECB code of ethics
Signing the PECB code of ethics
Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams which are related to this scheme. For more detailed information about the Foundation Exams and the overall Master Requirements, please go to the following link: https://pecb.com/en/master-credentials.
GENERAL INFORMATION
- Certification fees are included in the exam price.
- Training material containing over 450 pages of information and practical examples will be distributed.
- A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued.
- In case of exam failure, you can retake the exam within 12 months for free.
Training Calendar
Austria, Belgium, Canada, Germany, Ireland, Italy, Lichtenstein, Luxembourg, The Netherlands, Switzerland, United Kingdom, United States
Course | Dates | Location | Cost | Pay Now | Request Seat |
| Self Study Course | Online | $ 1250 | |||
May 8-May 11, 2024 |
| $ 2499 |
**This Live Online Course is scheduled for 4 pm - 8 pm Pacific Standard Time (U.S.).
1This Live Online Course is scheduled for 8 am - 4 pm Mountain US Time.
Albania, Bahrain, Belarus, Bosnia & Herzegovina, Bulgaria, Croatia, Czech Republic, Cyprus, Estonia, France, Greece, Hungary, Israel, Kosova, Kuwait, Latvia, Lithuania, Macedonia, Malta, Moldova, Montenegro, Oman, Poland, Qatar, Romania, Russia, Saudia Arabia, Serbia, Slovakia, Slovenia, Turkey, Ukraine, United Erab Emirates
Course | Dates | Location | Cost | Pay Now | Request Seat |
| Self Study Course | Online | $ 1050 |
*This Live Online Course is scheduled for 6-10 pm GST.
Afghanistan, Algeria, American Samoa, Angola, Antigua & Barbuda, Armenia, Australia, Azerbaijan, Bahamas, Bangladesh, Barbados, Benin, Bhutan, Botswana, Brunei, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, China, Comoros, Cook Islands, Ivory Coast, Dominica, DR Congo, Djibouti, East Timor, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Georgia, Ghana, Grenada, Guam, Guinea, Guinea-Bissau, Haiti, Hong Kong, India, Indonesia, Iran, Iraq, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kiribati, Kyrgyzstan, Laos, Lebanon, Lesotho, Liberia, Libya, Madagascar, Macau, Malawi, Malaysia, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Mayotte, Micronesia, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, New Caledonia, New Zealand, Niger, Nigeria, Niue, Norfolk Islands, North Korea, North Mariana Island, Pakistan, Palau, Palestine, Papua New Guinea, Philippines, Pitcaim Islands, Puerto Rico, Republic of the Congo, Rwanda, Saint Helena, Saint Kitts & Nevis, Saint Lucia, Saint Vincent & Grenadines, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Singapore, Solomon Islands, Somalia, South Africa, South Korea, South Sudan, Sri Lanka, Sudan, Swaziland, Syria, Tajikistan, Taiwan, Tanzania, Thailand, The Gambia, Togo, Tonga, Trinadad and Tobago, Tunisia, Turkmenistan, Tuvalu, Uganda, US Virgin Islands, Uzbekistan, Vanuatu, Vietnam, Wallis and Futuna, Western Sahara, Yemen, Zambia, Zimbabwe
Course | Dates | Location | Cost | Pay Now | Request Seat |
| Self Study Course | Online | $ 900 |
*This Live Online Course is scheduled for 6-10 pm GST.
Contact us
