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.

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.

Who should attend?

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

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

What is included?

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

BSI's Qualifications

Auditor Qualifications

This course forms part of our auditor qualification programme. Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses and exam.

Medical Devices Regulation (MDR) Qualifications

This course forms part of our MDR Practitioner Qualification. This qualification will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner status by successfully completing courses, exams and demonstrating practical application.

I'm interested, please send me more information about the course.