ISO 13485: 2016 - Understanding and Implementing The International Medical Device Quality Standard
Duration : 90 Minutes
Meena Chettiar,
Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A.SC in Chemical Engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar recently completed graduate cert Read more
This presentation will cover everything you ever wanted to know about the International Medical Device Standard ISO 13485:2016 Released on 01 March 2016 so you can start the gap assessment and make your quality system compliant to the new standard. Participants will gain a thorough insight into the specific quality system requirements of the all new International ISO 13485:2016 Quality System Standard requirements for Medical Devices. This extremely informative webinar will truly build your ISO 13485 knowledge from the fundamental quality principles. It will help you grow into fulfilling the quality and regulatory requirements as a professional working for medical device manufacturers of fully assembled devices and global suppliers manufacturing critical parts for the medical device industry for FDA registered medical device companies. Changes made to the key elements of this international standard will be discussed to pave the path for implementation of the changes in your quality system for manufacturing of your medical devices or parts for the medical device industry.
Course Objectives:
• Current vs Future expectations in the ISO 13485 world for your medical device
• A quick comparison of how the new standard is harmonized with 21 CRF 820 and GHTF Documents will be made
• Alignment of the standard to cater to the Medical Device Single Audit Program MDSAP) will be discussed
• Extension of the quality system rand risk management requirements for the life cycle of your medical device
• Incorporation of customer feedback and additional regulatory reporting needs for the new standards
• Alignment with ISO 9001 and discussion of timeline for full implementation of ISO 13485: 2016
Course Outline:
• Quality Management System(QMS) Requirements of ISO 13485: 2016 compared to ISO 13485: 2003
• Risk Based approach to all aspects of your QMS
• Changes to Management responsibility including expectations for management review
• Elevation in Competence and Training requirements
• Planning ( Design and Development including transfer) and Production controls and documentations needed
• Elevation in CAPA Process Expectations
• Expectations in the area of Communication with Regulatory Authorities
• Changes to Supplier Management Requirements for Risk Management in Purchasing
• Correlation of the new ISO 13485 requirements to FDA QSR 21 CFR 820 requirements
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Audit and Compliance Personnel / Risk Managers.
• Medical Device QA Professionals
• Design Engineers, R&D Engineers
• Upper Management in Medical Device Companies
• Supplier and Purchasing Departments in Device Companies
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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