UDI & Medical Device Labelling – Global Implementation
Practical Implementation of UDI, Labelling & Traceability for Medical Devices
A professional, implementation-focused programme on Unique Device Identification and medical device labelling across the EU MDR, US FDA and India MDR 2017. Across 16 practical lessons you learn → assign → create → verify → audit: label content, UDI-DI / UDI-PI / Basic UDI-DI, GS1, HIBCC and ICCBBA, EUDAMED and GUDID, packaging hierarchy and aggregation, UDI master data, barcodes and print quality, artwork control and line clearance, UDI change management, six device case studies and audit readiness. A final practical project has you label a fictional device end-to-end. Includes 15 premium checklists, SOPs and templates, a 30-question exam at 80% and a verifiable certificate.
Global rules
EU MDR, US FDA and India MDR 2017 side by side.
15 premium templates
Checklists, SOPs, decision tree and master-data sheets.
Hands-on project
Label a fictional device end-to-end, then audit it.
16 practical lessons · 16 premium templates · 30-question exam · certificate included
- 16 practical lessons
- 15 downloadable checklists, SOPs & templates
- 30-question final exam
- Certificate at 80% pass
Learn → Assign → Create → Verify → Audit
Implementation-focused, not theory-heavy — you do the work a UDI team does.
Learn
Label content, UDI-DI / UDI-PI and the EU, US and India rules.
Assign
Choose an issuing agency and build the UDI structure for each package level.
Create
Prepare the label, select the barcode and build the packaging hierarchy.
Verify
Fill the UDI data sheet and check it against EUDAMED / GUDID fields.
Audit
Run a label inspection and UDI audit, then raise CAPA.
Premium resources included
Printable inside the lessons and downloadable as Word / Excel files after enrolment.
- Global UDI implementation checklist
- EU MDR labelling checklist
- FDA UDI checklist
- India labelling checklist
- UDI-DI / UDI-PI decision tree
- UDI change-impact assessment
- Artwork approval checklist
- Label inspection checklist
- Packaging hierarchy template
- UDI master-data template
- UDI implementation SOP
- Label control SOP
- Artwork change-control form
- UDI audit checklist
- Practical case-study workbook
What you get
16 practical lessons
Tables, flowcharts, audit tips and six device case studies.
4 checkpoint quizzes
Test your recall after modules 4, 8, 12 and 16.
30-question exam
Final assessment with a 80% pass mark.
Verifiable certificate
Download instantly on passing, with a unique verification ID.
How enrolment works
Sign in
Use the email address that should receive course access.
Pay securely
Use the Enroll Now button to pay ₹499 through Cashfree.
Access activated
We verify the payment and switch on access for your registered email.
Who this programme is for
Regulatory affairs, quality, labelling and packaging engineers, artwork and supply-chain teams, master-data owners, internal auditors and consultants implementing UDI for medical devices
Curriculum
Full lesson content unlocks once your access is granted.
16 lessons · templates · certificate