Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation
Duration : 75 Minutes
Dev Raheja,
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologi Read more
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. It facilitates harmonized medical device regulatory requirements worldwide for quality management systems. This standard, applicable on a voluntary base, was designed in particular for medical device manufacturers. Officially named EN ISO 13485:2012, can be used by organizations in the design, development and production process for medical devices but also related services.
Course Objective:
The certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization. They tell you what to do but how you do is up to the companies. It’s your Quality System. Therefore you must develop your own details on system procedures, and the activities depending on complexity and potential risks of the device. This webinar covers the best strategies and best practices.
Course Outline:
• ISO 13485 benefits
• FDA’s Quality System Regulation requirements
• Document and record controls
• Quality management system
• Management responsibility
• Management commitment
• Quality policy
• Management review
• Resource management
• Infrastructure
• Work environment
• Purchasing
• Control of monitoring and measuring devices
• Internal auditing procedures
• Control of non-conformance
• Corrective and preventive action
• Process and design control
• Documenting risk management and controls
• Revisions to ISO 13485
• Overview of ISO 13485
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Senior management
• Entire engineering staff
• Entire Quality Assurance staff
• Production managers
• Manufacturing engineering staff
• Test engineering staff
• Regulatory affairs professionals
• Marketing Managers
• Service managers
• Project Managers and engineers
• IT professionals looking to make the design process efficient
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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