ISO 13485:2016 Deep Dive - Clause by Clause

To address the requirements of Medical Device Directives, manufacturers must demonstrate their commitment to the safety and quality of their medical devices. This course enables a clause by clause understanding of ISO 13485:2016, which provides an effective solution to meet the comprehensive requirements of an effective QMS. Learn to apply your knowledge to the development of an ISO 13485:2016 compliant QMS and maintain the on-going certification of your organization.

Who should attend?

Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.

Prerequisites:
There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course.

What will I learn?

On completion, you should gain the knowledge and skills to:

  • Explain the scope and the structure of ISO 13485:2016
  • Describe the requirements of ISO 13485:2016
  • Explain how to interpret the requirements of the standard within your organization
  • Develop your knowledge of how the requirements of ISO 13485:2016 are established and maintained in an organization
  • Identify the systems that are required to implement an ISO 13485:2016 QMS in order to gain or maintain certification to ISO 13485:2016

How will I benefit?

This course will help you:

  • Describe the requirements and structure of ISO 13485:2016
  • Interpret and apply requirements relevant to your organization
  • Appreciate how a QMS can be applied as a framework to produce safer medical devices
  • Evaluate how requirements can be effectively implemented to meet and maintain regulatory compliance

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

What is included?

This training course is HRDF approved under the SBL scheme.

On completion, you will be awarded an internationally recognized BSI Training Academy certificate.

Gain a Certificate of Achievement for this course

You can now qualify for a Certificate of Achievement, by passing the assessment requirements, including an end-of-course online exam, you’ll improve your professional profile and be able to:

 

  • Provide evidence of your learning
  • Demonstrate your competence


We will email your exam log-in details when you’ve finished the course. The exam is done online which means you can choose when and where to complete it. You are strongly advised to choose a time and a place where you will not be disturbed, and where you have access to a reliable internet connection. The exam takes approximately 80 minutes, is comprised with 40 multiple choice questions and you have up to 30 days to complete it – including one opportunity for a re-take.


Upon successful completion of this exam you will be awarded a Certificate of Achievement alongside your Certificate of Attendance. If, however, you decide not to complete the exam, you will still be awarded with a Certificate of Attendance.


Please talk to a member of our training team if you have any questions or queries in regards to the online exam and your training course.

Available as an in-house course

Call us and speak with our training advisors on running an in-house training.

  • Suitable for large groups
  • Flexible & convenient
  • Tailored for your needs