Course Description:

In the highly regulated medical device world, standards and regulations are continuously evolving to ensure that the highest levels of quality and safety are achieved. Through this course you will be able to assess your existing quality system processes and understand the changes that will need to be implemented in your organization to comply with the revised ISO 13485 Standard and to meet expectations from notified bodies.  Learn how you can prepare your quality and compliance teams to prepare for the new requirements while improving existing processes.

This 90-minute session will cover the latest updates and timelines around the 3^rd revision of ISO 13485 and an update on the current status of MDSAP.

Discussion topics include:

• Assessing the ISO 9001:2015 changes and its implications on the new ISO 13485:2016 standard.
• Discussing the current status of ISO 13485:2016
• Understanding the most critical changes proposed for the new Medical Standard.
• Analyzing the impacts of the ISO 13485:2016 key additions to an existing quality system
• Understanding the areas of increased emphasis and how Notified Bodies will assess the changes to the new standard.
• Understanding the objective evidence that would need to be in place to satisfy the new ISO 13485 Requirements.
• Discussing a strategy to conduct a robust gap assessment between the previous standard and the new changes.
• Evaluating industry best practices to effectively implement ISO 13485:2016.
• Highlighting the actions medical device manufacturers should be taking and pitfalls to avoid for a successful implementation of the new standard.

Who Will Benefit From This Course?

This course is ideal for:

• Professionals from Quality, Compliance and Regulatory Affairs who have oversight of medical device regulated processes and products 
• Auditors of medical device manufacturing firms (internal and external)
• Cross functional team members implementing standards and regulations