Course Overview
EN ISO 13485:2016+A11:2021 specifies requirements for a quality management system for quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device. To address the requirements of most of the regulatory requirements, manufacturers must demonstrate their commitment to the safety and performance of their medical devices.
This course enables a clause by clause understanding of EN ISO 13485:2016+A11:2021 which provides an effective solution to make effective QMS.
Course Objectives
The training provides:
- Understand the scope and the structure of EN ISO 13485:2016+A11:2021
- Understand the application of the risk-based approach in medical device QMS
- Explain how to interpret the requirements of the standard within your organization
- To Develop your knowledge of how the requirements of EN ISO 13485:2016+A11:2021 are established and help the organization to fulfil the regulatory requirements.
How you will be benefit
- Champion ISO 13485 plant benefits
- Fulfill ISO 13485 standard / regulatory requirements.
- Prepare an action plan to get started.
- List the steps to implement ISO 13485.
- Give participants an awareness of ISO13485 and its alignment to respective Quality System Regulation
- Assist participants in the relationship between QMS and registration
- Identify what ISO13485 and also what is regulatory expectation
Who Should Attend
This course is designed for individuals in the medical device industry who are involved in the development and maintenance of a quality management system based on EN ISO 13485:2016+A11:2021.
No prerequisites are necessary for this course.
Our Solutions
- This course can be run in-company around the world
- We can tailor the content to focus on your requirements.
- This approach makes perfect sense for groups of 4+ delegates, enhancing cost effectiveness as well as team bonding.
- Classroom accompanied by Lectures, Experience Sharing, Role-plays, Interactive Group Activities, Experiences, Simulation Activities and Feedback
- Delegate manuals and certificates of Attendance will be provided
Course Content
Day 1
Module 1: EN ISO 13485:2016+A11:2021 audited clause interpretation
- Clause 4 – 6
- Understanding the regulatory requirement like UDI (Unique Device Identification)
- Understanding the EU requirement on medical device
- Risk based approach to the appropriate process
- Case study (real sample of audit finding)
- Q & A session
Day 2
Module 2: EN ISO 13485:2016+A11:2021 clause interpretation
- Clause 7 – 8
- Product Risk
- Understanding the concept of Validation (Design qualification, installation qualification, operational qualification, Performance qualification, revalidation)
- Case study (real sample of audit finding)
- Q & A session
