ISO 13485 Trainings

ISO 13485 Foundations training is a course designed to explain the requirements of ISO 13485 and how to apply them in different types of medical device processes.

Besides the ISO 13485 Foundation course, there are also ISO 13485 Internal Auditor, Lead Auditor, and Lead Implementer courses in which information about auditing and implementation of the standard is presented, and also how to lead audit and implementation teams.

ISO 13485 training is recommended for any person interested in implementing the standard in an organization or who wants to learn the basics of conducting an audit against ISO 13485 requirements. This may include consultants, auditors, or any individual involved in the implementation of ISO 13485 in their companies.

If you are an employee in a company implementing the ISO 13485 standard, you need to attend ISO 13485 training so you can learn the ISO 13485 requirements and how to apply them to your business.

If you are an ISO 13485 consultant and auditor, the training will help you to increase your knowledge and understanding, and maybe fill in some knowledge gaps, so you can improve your work and finish your projects in less time and with better quality.

If you are an ISO 13485 consultant and auditor, the ISO 13485 training and certificate will prove your knowledge and competence, helping you to position yourself better in comparison with the competition and extend your business. Even if you are not a consultant, and you just work in a company implementing the ISO 13485 standard, this training and certificate will also help you prove your competence in front of the management and advance in your career.

There are four types of ISO 13485 courses:

• ISO 13485 Lead Implementer course – intended for advanced practitioners and consultants.
• ISO 13485 Lead Auditor course – intended for auditors in certification bodies and for consultants.
• ISO 13485 Internal Auditor course – intended for people who will perform internal audits in their company.
• ISO 13485 Foundations course – intended for people who want to learn the basics of the standard, and the main steps in the implementation.

You can read this article to help you decide which course is the best fit for your needs: https://advisera.com/training/compare/

The cost of the trainings and exams for individuals are different in various countries, but these costs are usually displayed very transparently by each training provider.

Advisera ISO 13485 courses are available online without any cost. The student should pay only if he or she would like to take the exam and obtain the certificate.

Advisera online certification is very reasonably priced compared to the costs of in-classroom training, and the travel costs associated with it. As indicated above, the training videos can be viewed for free, and if you wish to take the exam and earn the certificate, the prices for these ISO 13485 training courses are as follows:

• ISO 13485 Foundations course – $349
• ISO 13485 Internal Auditor course – $649
• ISO 13485 Lead Auditor Training course – $1797
• ISO 13485 Lead Implementor course – $1797

The right course for you is very much dependent on which role you will play in the implementation and maintenance of the Medical Device Management System.

You can read this article to help you decide which course is the best fit for your needs: https://advisera.com/training/compare/

Depending on the course type and delivery method, you may need from one day, for the Foundations course, up to five days for the Lead Auditor and Lead Implementer courses.

All Advisera ISO 13485 courses are available online as pre-recorded videos, and you can access them from anywhere at any time. You will need eight hours to complete the ISO 13485 Foundations course, 15 hours for the ISO 13485 Internal Auditor course, and 20 hours for the ISO 13485 Lead Auditor or Lead Implementer course.

When searching for ISO 13485 training, you should first decide what type of training you prefer, online or classroom based. Then, you should assess your current knowledge about the standard, so you can know if you should look for a beginner or more advanced course, and what your role will be in the project. Once you know the answers to these two questions, you can start searching for accredited training centers/providers. When you find a course, always check who the trainer is and what his/her experience is with the standard and the industry, as well as the course accreditation.

The Advisera training courses are accredited by ASIC, Accreditation Service for International Schools, Colleges, and Universities, which means that your certification is highly regarded in the industry.