ISO 13485 – Medical Device – Quality Management Systems –Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers, developers, and suppliers. The standard details the requirement for quality management systems, to meet customer requirement and allows the incorporation of applicable regulatory requirements within an organization’s quality management system

Participants Receive:-       

• Slides including exercises
• Awareness Certificate of the course

Course Facilities:-

All course facilitators are highly qualified and experienced both in training and assessment of Medical Device Quality Management Systems We strongly believe that the experience in Environment Management Assessment and Training skills is a right combination to deliver a practical training course. They are selected on their ability to make BSCIC courses both practical and enjoyable.

Learning Objectives:- 

By the end of the course you will be able to understand:-

• Explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
• Identify the relationship between ISO 13485:2016 and European Medical Device Directives
• Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide

Who Should Attend?

• Medical Device Manufacturers.
• Quality Professionals
• Regulatory Professionals
• Internal and external Auditors
• Consultants and anyone involved with the implementation of the standard

Course Content and Structure:-

The course of Medical Device Quality Management Systems includes a series of presentations, Examples, Exercises involving group activities, Brain Storming, Case Studies, Readings and Sharing of Practical Experiences.

Duration:-

One Day