ISO 13485:2016 - What are the hot topics and changes?
Duration : 90 Minutes
Dr. Frank Stein,
Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international p Read more
In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.
Course Objectives:
The ISO 13485:2016 is the essential standard for quality management systems for medical device manufacturer, importer, distributors and dealers in Europe and in the international markets. This standard has received some changes e.g. responsibility of outsourced processes, computer system validation, control of nonforming products etc. The understanding of this changes and how to implement last minute changes until March 2019 is essential to keep the certificates valid after March 2019.
• Introduction and who should apply the ISO 13485:2016
• Overview about the changes of the ISO 13485:2016
• Explaining of each change
• Smart and fast ways to implement the changes in your quality management system
• Fast track internal audit to approve the changes
Why Should You Attend:
Attend this webinar to understand, what are the changes to the previous standard and how to implement the changes in your current quality management system in a simple and quick way. Your implementation time until March 2019 is short and need smart ideas to reach the right level to pass the quality management audit by your certification company.
Course Outline:
• Closer regulatory binding of the ISO to the new EU MDR
• Adjustments in the management review
• Responsibilities for outsourced processes
• Labeling, UDI
• Changes in the control of nonconforming products
• How to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
Personnel in the areas of:
• R&D
• Manufacturing Engineering
• Design Engineering,
• Design Assurance
• Quality Assurance
• Operations
• Document Control
• Supplier and Purchasing Departments in Device Companies
• Compliance Personnel / Risk Managers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
