The Rush for ISO13485: 2016


Instructor: Yuval Shapiro
Product ID: 705624

  • Duration: 60 Min
In this session Mr. Shapiro will provide an overview of the history of the ISO13485, and the newly introduced changes. The Speaker will also discuss how the changes interact with regulatory requirements, and how to face the new changes. The webinar will focus on key provisions and considerations when establishing a QMS as per the ISO13485: 2016, and identify pitfalls that should be avoided.
Last Recorded Date: Mar-2018


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Why Should You 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 on 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.

Areas Covered in the Webinar:

  • General overview of ISO13485: 2016
  • New changes to the standard, especially Risk Approach
  • Best practices for addressing the standard
  • Best practices for implementation and potential pitfalls

Who Will Benefit:

  • Medical Devices manufacturers
  • Engineers
  • Managers and Directors
  • Quality Assurance
  • Regulatory Affairs
  • Production
  • Team Leaders
Instructor Profile:
Yuval Shapiro

Yuval Shapiro
Founder, Quality with Value

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.

More than 20 years of experience in QA; including MD&D RA & QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000‎; EMC & Safety Certifications.

Topic Background:

On March 2016 ISO – the International Standards Organization, published the latest version of the ISO13485 - Medical devices -- Quality management systems -- Requirements for regulatory purposes. A 3 years period was granted to organizations with a QMS certified to ISO13485 to accommodate to the new standard.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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