Master Medical‑Device Risk Management. Maintain Compliance. Power Safety Excellence.
Topics Covered:
Introduction to ISO 14971:2019: Build a solid foundation by mastering core principles and definitions that underpin the standard
Links to Regulatory requirement : Learn how ISO 14971 aligns seamlessly with FDA 21 CFR 820.30(g), EU MDR/IVDR, and ISO 13485 to ensure full compliance
Business & Patient‑Safety Benefits: Discover how robust risk processes improve approvals, reduce costs, and build trust—from concept to clinic
ISO 14971:2019 – Clause‑by‑Clause Implementation: Break down each clause—from planning and analysis to risk control, evaluation, and post-production review—into actionable steps
Hands‑On Risk‑Register Workshop: Turn theory into practice—work with real case studies to identify hazards, assess risks, apply controls, and document traceability
Eligibility : Perfect for life-science and pharma graduates, QA/RA professionals, R&D engineers, and medical-device manufacturing or supply-chain teams.
Why Enroll with us ?
Action‑Oriented Learning: Move beyond theory with intensive, practicum-driven sessions.
Expert Instruction: Learn from trainers with deep ISO 14971 and MDR/MDSAP implementation experience
Career Value: Earn recognized certification and essential skills sought by med‑tech and regulatory teams worldwide
Training Dates: 24th and 25th July 2025
Mode: Online
Duration: 2 Days (From 10 AM - 6:00 PM)
Training Fee: 10,000 (Including GST) for Indians
For other Nationality : 250 USD
Discount applicable for AMTZ Manufactures; AiMeD Members, UdaiMeD Members, CII Members, PWMAI Members & IBSC Partners
Last Date of Registration : 15th July 2025
Examination will be conducted online via an E-Platform. Certificate will be provided to each Participant upon Successful Completion of the Assessment.
Note: Minimum 10 enrollments to start the batch.
Once fee paid no refund or transfer.
For Quotations
Contact: N. Naresh Kumar, Scientist‑E, IBSC
📱88973 30990 │ ✉️n.nareshkumar@ibsc-amtz.in
For payment scan this QR code and pay INR 10,000 and WhatsApp the payment screenshot to 9985001873 or 8897330990
| S.No | Start Date | End Date | Total Amount (INDIA) | Total Amount (Foriegn) |
|---|---|---|---|---|
| 1 | 2025-07-02 | 2025-08-31 | 10,000 | 20,000 |
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