QMSR Readiness
course description
This two-hour course introduces the participants to the basic requirements of the QMSR, which now incorporates ISO 13485:2016 as a mandatory standard. The introduction of risk management throughout the entire device lifecycle will be discussed, as will the impact of the QMSR on the organization’s quality management systems. Upon completion of this course, participants will be able to develop a practical roadmap for QMSR readiness and prepare the organization for FDA inspections.
course specifics:
- Participant Cap - 30
- Delivery - Virtual
- Course Length - Two (2) hours
- Printed Materials - Sent to company or college prior to delivery for them to print and disseminate