Understanding ISO 13485-FDA Requirements for Medical Devices 2015

Understanding ISO 13485: 2015 Requirements for Medical Devices Instructor: Meena Chettiar Product ID: 500883 Description The speaker will provide the background behind ISO 13485: 2015 and identify all areas that are being changed from the current ISO 13485: 2003 requirements for medical devices manufacturers. Steps involved in updating your current quality system to fulfill the updated quality requirements will be discussed. Timelines for compliance to the new standard and recommended steps will be clearly identified for the audience. Why Should you Attend: Attend this 75 minutes webinar to remain complaint to the medical device regulatory requirements for your global customers. The areas covered in this session are: History behind the changes being introduced to ISO 13485 in 2015. What are the quality system elements that are being changed? What does this mean to your established quality system under ISO 13485: 2003 and 21 FR 820? A step by step approach to becoming compliant to the new regulatory requirements will be covered by the experience speaker who has been following through every step of this global process. You will also learn about the timelines to focus on and quickly switch gears to the elevated regulatory expectations under ISO 13485: 2015. Objectives of the Presentation: The key learning objectives of the presentation are: What is in store for currently marketed medical devices when ISO 13485: 2015 gets launched? Which areas are being revamped under ISO 13485: 2015? Where does one begin? What sort of gap analysis is a must? When is your quality system expected to be completely switched over to cater to the changes being introduced? Who can Benefit: Quality and Regulatory Managers Quality Assurance Supplier Management and auditing professionals in the medical device or medical device-pharmaceutical industry quality professionals all across the world. ISO 13485: 2015, Medical device regulations, Quality system for medical devices