Webinar on The Rush For ISO13485: 2016 · how to face the new changes. The webinar will focus on...
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The Rush For ISO13485: 2016 Date : 11 April 2019 Webinar on
Transcript of Webinar on The Rush For ISO13485: 2016 · how to face the new changes. The webinar will focus on...
The Rush For
ISO13485: 2016Date : 11 April 2019
Webinar on
Provide a general overview of ISO13485: 2016
Examine new changes to the standard, especially Risk Approach
Discuss best practices for addressing the standard
Discuss best practices for implementation and potential pitfalls
Areas Covered
This webinar
presents to the
participants
the new
requirements
of the
standard and
how they
correlate with
the regulatory
changes in the
EU.
PRESENTED BY:
Yuval Shapiro is the founder of QWV – Quality with Value, QA/RA Services. An expert for products and companies primarily related to medical devices that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Military, Telecom & Medical Devices), and give a high-value contribution to quality and reliability projects related to the medical device and telecom industries.
Date : 11 April 2019
Time : 01 : 00 PM EST
Duration : 60 Minutes
Price: $225
In this session, Mr. Shapiro will provide an overview of the historyof the ISO13485 and the newly introduced changes. He will alsodiscuss how the changes interact with regulatory requirements, andhow to face the new changes. The webinar will focus on keyprovisions and considerations when establishing a QMS as per theISO13485: 2016, and identify pitfalls that should be avoided.
On March 2016 ISO – the International Standards Organizationpublished the latest version of the ISO13485 - Medical devices --Quality management systems -- Requirements for regulatorypurposes. A 3 years period was granted to organizations with aQMS certified to ISO13485 to accommodate to the new standard.
This training is to provide an overview of the new ISO13485: 2016standard, present the history of it and display the main changesfrom the previous revision.
Webinar Description
QA/RA engineers
QA/RA managers
Who Should Attend ?
Why Should Attend ?
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 on how to address the certification process will be introduced.
