ISO 14971:2019 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2019 are applicable to all stages of the life-cycle of a medical device.
- Provide a basic understanding of Risk Management Approach in Medical Devices.
- Illustrate the concepts though example.
Date and Time
Date : 3rd April 2020
Time : 11.00 am to 1.00 pm
Who should attend ?
- Design Professionals in Medical Devices Field
- QA Professionals in Medical Devices Field
- Risk Management Professionals
- Core Team Members of Medical Devices – QMS Team
- Internal Auditors of Medical Devices QMS
- External Auditors of medical Devices QMS
- Students having interests in Medical Devices
- Basic Definitions
- Risk Management Plan
- Reference Standards
- Product Design Lifecycle and Phases
- Product Description
- Responsibilities and Authorities
- Hazard Identification and Risk Analysis
- Risk Evaluation, Risk Classification and Acceptance Criteria
- Risk Treatment, Residual Risk and Further Mitigation Plan
- Risk Benefit Analysis
- Production and Post-Production Information Monitoring
- Risk Management Report
Softcopy Certificate of successful completion shall be issued to all the delegates who attend entire duration of the course.
Rs. 1250/- + 18 % GST Only
Registration with confirmed payment will be closed 24 Hours before the scheduled time of Webinar.
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In case of schedule cancellation by the delegate, fees will be non-refundable.