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This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.
Prior to engaging the process of establishing and certifying a QMS for medical devices or enhancing the QMS to the newly introduced requirements, a review of those requirements and how to approach them is important.
The webinar will present the evolution of the ISO13485 since its initial publication in 1988.
Also, the webinar will exhibit the last evolvement: Risk Approach and Regulatory Requirements Addressing.
In addition, timetables and several tips how to address the certification process will be introduced.
Why should you Attend:
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