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Recorded Webinar
Global Medical Device Standards State-of-the-Art
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Standards management has become a cornerstone for effective medical device quality management. Global regulatory bodies require the solutions adopted by device manufacturers take the generally acknowledged "state-of-the-art" into account. Consensus standards such as those developed by the International Organization for Standardization (ISO) define the current state-of-the-art. Since conformance to standards can lead to a presumption of conformity with the associated legal requirements, it is critical for medical device firms to correctly identify and seek conformance with the standards that apply to their devices.
Medical device designers and manufacturers face great challenges to determine the standards that apply to their devices. This webinar will give you the tools needed to identify the applicable standards, procure them economically, and stay up to date as they are revised. The webinar will teach you how to maintain a "state-of-the-art" medical device and quality management system.
Areas Covered in the Webinar:
- Finding standards information online
- Keeping track of new/revised standards
- Tips for saving money when buying standards
- Identifying standards that apply to particular device types
- Proving equivalence of standards issued by different standards bodies
- How to perform "state of the art" reviews
Webinar Motivation :
- Documents of external origin such as standards must be controlled to meet medical device quality system requirements (ISO 13485, clause 4.2.3)
- Regulatory bodies require the solutions adopted by the manufacturer for their quality system and device design to take the generally acknowledged 'state of the art' (e.g., standards) into account.
- Standards management has become a cornerstone for effective quality management.
Webinar Excel Workbook comparing standard pricing from several sources & Microsoft Word “State of the Art Review Report” template will also be shared.
Who should attend
- Document Control Managers
- Quality Assurance Engineers, Managers
- Regulatory Affairs Specialists, Managers
- Research & Development Engineers, Managers
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