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
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.
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
Educational approach
- This training is based on both theory and best practices used in the implementation of a MDQMS
- Lecture sessions are illustrated with examples based on case studies
- Practical exercises are based on a case study which includes role playing and discussions
- Practice tests are similar to the Certification Exam
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Course agenda
Day 1: Introduction to ISO 13485 and initiation of a MDQMS
Day 2: Plan the implementation of a MDQMS
Day 3: Implementation of a MDQMS
Day 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit
Day 5: Certification Exam
SMATICA is authorized to deliver PECB ISO 13485 Lead Implementer, for learners holding National ID / Passport / Driving License of following countries
| Region | Authorized Countries |
|---|---|
| North America | United States of America, Canada |
| United Kingdom & Netherlands | United Kingdom, Ireland, Netherlands, Curacao, Aruba, Sint Maarten, Anguilla, Bermuda, British Virgin Islands, Cayman Islands, Monserrat, Turks, Caicos Islands. |
| Europe | Sweden, Norway, Denmark, Germany, Liechtenstein, Austria, Switzerland, Belgium, Luxembourg, Italy, Albania, Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Cyprus, Estonia, Greece, Hungary, Kosovo, Latvia, Lithuania, Macedonia, Malta, Moldova, Montenegro, Poland, Romania, Serbia, Slovakia, Slovenia, Turkey, Ukraine, Finland, Iceland, Azerbaijan, Georgia, San Marino, Armenia, France ( Live online training only ) |
| Middle East | Saudi Arabia, United Arab Emirates, Bahrain, Israel, Kuwait, Oman, Qatar, Egypt, Iraq, Yemen, Syria, Jordan, Lebanon, Palestine |
| Africa | Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Ivory Coast, DR Congo, Djibouti, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Jordan, Kenya, Lebanon, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mayotte, Morocco, Mozambique, Namibia, Niger, Nigeria, Palestine, Republic of the Congo, Rwanda, Saint Helena, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Syria, Tanzania, Togo, Tunisia, Uganda, Western Sahara, Yemen, Zambia, and Zimbabwe. |
| Asia-Pacific | Afghanistan, Armenia, Australia, Azerbaijan, Bangladesh, Bhutan, Brunei, Cambodia, China, Cook Islands, East Timor, Fiji, Georgia, Hong Kong, India, Indonesia, Japan, Kazakhstan, Kiribati, Kyrgyzstan, Laos, Macau, Malaysia, Maldives, Marshall Islands, Micronesia, Mongolia, Myanmar, Nauru, Nepal, New Caledonia, New Zealand, Niue, Norfolk Islands, Pakistan, Palau, Papua New Guinea, Philippines, Pitcairn Islands, Samoa, Singapore, Solomon Islands, South Korea, Sri Lanka, Taiwan, Tajikistan, Thailand, Turkmenistan, Uzbekistan, Tonga, Tuvalu, Vanuatu, Wallis and Futuna, Vietnam. |
| Caribbean | American Samoa, Guam, Northern Mariana Island, Puerto Rico, US Virgin Islands, Antigua & Barbuda, Bahamas, Barbados, Dominica, Grenada, Haiti, Jamaica, Saint Kitts and Nevis, Saint Lucia, Saint Vincent & Grenadines, Trinidad & Tobago |
