ISO 13485:2016 Awareness Training

Course Overview

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

 

Covered Topics

Basic Introduction to ISO 13485: 2016

Relation ISO 9001:2015 / ISO 13485:2016

Key issues addressed by ISO 13485:2016

Integration of Risk Management ISO 14971 in ISO 13485

 

Who Should Attend This Course?

Medical Device Manufacturers.

Quality Professionals

Regulatory Professionals

Internal and external Auditors

Consultants and anyone involved with the implementation of the standard

 

Study Material

Lecture sessions are illustrated with examples based on case studies

Practical exercises are based on a case study which includes role playing and discussions

Practice tests are similar to the Certification Exam

 

End Of Course Instruction

After completing the session and passing each session examination, the students can take the final exam. Once the final exam is passed, then it is considered as an end of course.