OVERVIEW
This 2-hour session will provide the attendees with experience gained in providing transition assistance to medical device companies over the last 2 years. Attendance includes examples of how to address the gaps most often observed and practical advice for managing transition activities as well as managing your certification audit for ISO 13485:2016.
WHY SHOULD YOU ATTEND
All organizations that are part of the medical device supply chain are required to establish a quality management system that conforms to ISO 13485. The transition period is coming to an end for the third edition of the standard and certifications to the second edition will expire by March 2019. If you haven’t completed the transition your organization may not be able to market devices in 2019 or you may have corrective actions forced on you by your customers. This webinar will provide you with practical actions you can take to ensure your certification to this new edition of the standard is obtained.
AREAS COVERED
- Role of the organization
- Risk-based approach
- QMS Software validation requirements
- Management Responsibilities (review)
- Competence/Awareness of personnel
- Updates to product realization including risk management
- Updates to production/service
- Post-market surveillance (Feedback/Complaint handling)
LEARNING OBJECTIVES
The Transition Period is coming to an end soon (February 2019). What are the key changes that require attention? Based on experience with transition, what areas are generally the biggest gap and what action should you take to ensure certification is obtain/maintained going into 2019?
WHO WILL BENEFIT
- SMEs doing the work
- Quality assurance
- Regulatory Professionals
- Biostatistics
- Data Management
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