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ISO 13485 is a quality standard for the manufacture and design of medical devices. This ISO 13485 course guides on the standard in detail, delivering the understanding of its clauses helping the businesses in improving manufacturing quality while reducing defects.
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ISO 13485:2016 is an international standard that defines the requirements of quality management systems for organisations that design, develop, manufacture, and implement medical devices. It also includes services regarding design and development of material or component parts used in the medical devices. The most recent version of the standard was published in March 2016.
Following modules/ topics will be covered in ISO 13485 course:
Module 1: Introduction to ISO 13485:2016
Module 2: A Overview of ISO 13485:2016 Requirements
Module 3: Implementation Phases of the ISO 13485 Frameworks
Who Should Attend?
This course is suitable for professionals involved in the manufacture and design of medical devices or related field.
There are no pre-requisites for attending this course.
Virtual classroom trainings are held using video conferencing software. A trainer leads the class for the duration of course. Delegates may attend the session using PC, laptop or tablets.
Minimum of 20Mbps is recommended internet speed.
No, this course is not accredited by any certification body.
Tecknologia trainers are highly experienced practitioners with excellent training delivery capabilities. Our trainers are accredited by various bodies for relevant training deliveries.
This instructor lead course includes following:
Refreshments (tea/ coffee) will be provided free at venue for classroom courses.