ISO 13485:2016 Awareness Training

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 life-cycle 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.

Learning Objective:

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 will be able to :- Understand the requirements of ISO 13485 Conduct effective internal audits in their own organizations

Who Should Attend?

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.

Course Contents:

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.