Why should you attend?
ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.
After completing this course, you can sit for the exam and apply for the “PECB Certified ISO 13485 Foundation” credential. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.
Who should attend?
- Individuals involved in Medical Devices Quality Management
- Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
- Individuals interested to pursue a career in Medical Devices Quality Management
- Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Understand the approaches, methods and techniques used for the implementation and management of a MDQMS
- Lecture sessions are illustrated with practical questions and examples
- Practical exercises include examples and discussions
- Practice tests are similar to the Certification Exam
Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
Day 2: Medical Devices Quality Management System requirements and Certification Exam
SMATICA is authorized to deliver PECB ISO 13485 Foundation, for learners holding National ID / Passport / Driving License of following 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|