Risk Management (ISO 14971), UDI & Labelling
3 Underrated Concepts of MDR in Detail
3 Days Training Course
Our interactive and activity based 3 Days Training Course covers these 3 ‘often overlooked’ concepts of MDR in detail helping manufacturers of medical devices to gain a deeper knowledge of these elements to implement with ease in practical life.
What it Covers?
- Risk Management of Medical Devices as per ISO 14971
- Concepts of UDI as a part of the EU traceability system
- GS1 and UDI
- MDR compliant Labelling wit ISO 15223
Who Should Attend?
- Quality Managers
- Quality Engineers
- Design Quality
- Regulatory Affairs Specialist
- Medical Affairs Specialist
- Any personnel involved with the processes concerning medical devices
Certification Requirement
A ‘Certificate of Attendance’ will be issued at the end of the course. A special ‘Certificate for Exceptional Participation’ will also be issued depending upon your contribution in the form of your participation and interaction.
Course Breakdown – What You’ll Learn
Day – 1
Risk Management
- Module 1
- Introduction to Risk Management and ISO 14971
- Important Definitions
- General Requirements of Risk Management System
- Risk Analysis
- How to Evaluate Risk
- Module 2
- Risk Control
- Evaluation of Residual Risk
- Risk Management Review
- Production and Post-Production Activities
Day – 2
UDI
- Module 1
- Introduction to UDI
- 3 Basic Concepts – Basic UDI-DI, UDI-DI and UDI-PI
- Differentiating Basic UDI-DI and UDI-DI
- Allocation Bodies
- Understanding UDI-PI
- Module 2
- Understanding GMN and GTIN from GS1
- GTIN allocation rules from GS1
Day – 3
Labelling
- MDR Compliant Labelling with ISO 15223
ENROLL NOW!!
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