ISO13485: 2016 - Quality Management Systems for Medical Devices

The webinar will will Provide a general overview of ISO13485: 2016, And Discuss best practices for implementation and potential pitfalls.

Yuval Shapiro
Instructor:
Yuval Shapiro
Date:
Monday, October 7, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502724

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
Price Detail Options
Overview:

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.

Why should you Attend:

  • The background for the revised ISO13485
  • The principles of ISO13485
  • ISO13485: 2016 sections
  • Main changes from the ISO13485: 2003

Areas Covered in the Session:
  • 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

Who Will Benefit:
  • Quality Managers
  • Quality Engineers
  • Engineering Managers
  • R&D Manager


Speaker Profile
Yuval Shapiro is the founder of QWV - Quality with Value, QA or 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 and D RA and QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). More than 20 years of experience in QA; including MD&D RA & QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH and S Systems; QA or RA representative in R and D Projects. Risk Analysis as per ISO14791 & ISO31000. EMC & Safety Certifications.




Your Recently Viewed Webinars

Payment Methods

Contact Us

NetZealous LLC,
39658 Mission Boulevard, Fremont,
CA 94539, USA.

Information

  Refund Policy
  +1-800-447-9407
  Fax: 302 288 6884
  support@compliance4All.com