Speaker Profile


Yuval Shapiro

Founder,QWV – Quality with Value, ,

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.

  •  Thursday, September 12, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • $150.00
CAPA - BulletProof Per ISO13485: 2016

FDA, EU Notified Bodies and other regulatory authorities investigate the capability of organizations to identify processes that require corrective and preventive actions.

  •  Wednesday, September 25, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • $150.00
Creating Optimal Sampling Plans

A sampling plan is a term widely used in research studies that provide an outline on the basis which of research is conducted. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the population.

  •  Monday, October 7, 2019
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • $150.00
ISO13485: 2016 - Quality Management Systems for Medical Devices

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.

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  • Recorded
  • View Anytime
  • 60 Minutes
  • $190.00
CAPA - BulletProof Per ISO13485: 2016

FDA, EU Notified Bodies and other regulatory authorities investigate the capability of organizations to identify processes that require corrective and preventive actions.

  • Recorded
  • View Anytime
  • 60 Minutes
  • $190.00
Creating Optimal Sampling Plans

A sampling plan is a term widely used in research studies that provide an outline on the basis which of research is conducted. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the population.

  • Recorded
  • View Anytime
  • 90 Minutes
  • $190.00
ISO13485: 2016 - Quality Management Systems for Medical Devices

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.

  • Recorded
  • View Anytime
  • 60 Minutes
  • $390.00
CAPA - BulletProof Per ISO13485: 2016

FDA, EU Notified Bodies and other regulatory authorities investigate the capability of organizations to identify processes that require corrective and preventive actions.

View All

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