Description
Why should you attend?
This ISO 13485:2016 Overview course equips professionals with the expertise to assess and improve medical device Quality Management Systems (QMS) while ensuring compliance with global regulatory standards like FDA and EU MDR. Participants gain advanced auditing skills, enabling them to identify risks, address non-conformities, and drive continual improvement. This certification enhances career opportunities, establishes credibility, and supports organizational growth by ensuring consistent product quality and safety. Globally recognized, this course fosters efficient processes, effective risk management, and alignment with industry best practices, making it invaluable for professionals in the medical device sector.
Who should attend?
This training course is intended for:
- Quality managers and engineers
- Regulatory Affairs professionals
- Internal and external auditors
- Consultants
- Medical device manufacturers
- Aspiring auditors
- Suppliers to medical device companies
Learning objectives
This course enables you to:
- Gain a comprehensive understanding of the ISO 13485:2016 standard and its application in medical device Quality Management Systems.
- Drive continual improvement by learning how to align audit findings with organizational goals for improved quality and compliance.
- Meet certification requirements.
- Leadership requirements for running and continually improving the management system.
Educational approach
This training course:
- Utilizes varied teaching methods, including role-playing.
- Emphasizes active listening, to ensure that participants have the opportunity to engage in meaningful dialogue and actively absorb the information provided.
- Facilitates interaction between participants and with the instructor.
- Incorporates a major concept focus, presenting essential terminology in order to facilitate a clear and concise understanding of the subject matter.
Class Format(s)
Instructor-led (live in-person, virtual)
Certification(s)
Attendees successfully completing the training provided receive a Certificate of Participation, which includes the number of training hours attended.
Content Style
Lecture and Workshop
Project/Actual Training Days
2 days
