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
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.