The Rush for ISO13485: 2016
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.
In this session, Mr. Shapiro will provide an overview of the history of the ISO13485 and the newly introduced changes. He 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.
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.
This training is to provide an overview of the new ISO13485: 2016 standard, present the history of it and display the main changes from the previous revision.
- 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
Course Level - Intermediate
Who Should Attend
QA/RA engineers and QA/RA managers
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.