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.
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:
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
Speaker
Yuval ShapiroCourse Provider
Yuval Shapiro,
