ISO 13485 Medical Devices – Quality Management System Awareness Training Program


Most countries have rules and regulations related to safety for almost all products. The focus on environmental aspects is growing, ranging from the use of hazardous substances to energy efficiency and recycling. Compliance with regulations is therefore no longer just a matter of getting the design in line with product safety specifications, it relates to the whole lifecycle and sustainability of the product. The common denominator for most of these rules and regulations is a need, mandatory or on a voluntary basis, for an independent body to examine the product and make a statement about its compliance. Over the last decade product compliance issues have gone through a rapid change. Once manufacturers had to pass through a cumbersome process of getting their product approved for every country they wanted access to. The processes were often different and so were the technical requirements. Today most products are realized through complex interactions between component suppliers, sub-unit suppliers, remote manufacturing plants and distribution hubs. As a result, new risks have emerged resulting from added complexity, distance and culture.


To enable participants, to gain awareness, practical understanding and knowledge related to ISO 13485 and effectively conduct internal audits within their organization. At the end of the course, participants willbe able to :-  Understand the requirements of ISO13485  Conduct effective internal audits in their own organizations


Following modules will be covered :-  Purpose & structure of ISO 13485 and how does it support business improvement.  ISO 13485 requirements and how can you demonstrate that they are met.


Professionals from Medical Device manufacturing industries, Management Representatives, Project Team Members of ISO 13485 Audit, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Process.


 The course is approved by DNV- GL Training Academy. The certificate is valid for three years and recommended for recertification 


3 days 


This course has been designed with input and feedback internationally from several trainers, customers and training consultants. The course design reflects a high level of interaction between the trainer and the participants. The learning sessions include real-life examples, the knowledge of which can be applied to the participant’s organizations 


On successful completion of the course, DNV-GL certificate will be issued to the successful participant.