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8 of 8 courses
Medical Device Packaging Validation — A Complete Guide
ISO 11607-1/-2, seal integrity, ageing, transport and audit-ready files
A complete 10-module guide to medical device packaging validation covering ISO 11607-1 (materials and SBS design), ISO 11607-2 (IQ/OQ/PQ), seal integrity and strength (ASTM F88, F1929, F1140, F2096), sterilisation compatibility, distribution simulation (ASTM D4169, ISTA), accelerated and real-time ageing (ASTM F1980), labelling and UDI, packaging risk management and CAPA, and regulatory submissions.
Regulatory Affairs Mastery
Flagship 40–50 hour self-paced regulatory affairs program
A beginner-to-advanced regulatory affairs program covering EU MDR, US FDA, India MDR, ISO standards, technical documentation, clinical evaluation, risk management, labelling & UDI, post-market surveillance, AI/SaMD, audits, real industry case studies and career mastery — across 17 in-depth modules and ~150–200 lessons.
Medical Device Fundamentals
The essentials every medical device professional must know
An introductory course covering what a medical device is, how it is classified in the EU, US and India, the full product life-cycle, the roles and responsibilities of every player in the industry, and the terminology used across standards and regulations.
Indian MDR — Medical Devices Rules, 2017
CDSCO licensing, classification, vigilance & post-market for India
India's Medical Devices Rules, 2017 (effective 1 January 2018). Covers risk classification, CDSCO/SLA licensing forms (MD-5, MD-9, MD-15, MD-42), Fifth Schedule QMS, labelling, clinical investigation, MvPI vigilance, recalls, IVDs and recent amendments.
21 CFR Part 820 — QMSR
FDA Quality Management System Regulation
The amended Part 820 incorporates ISO 13485:2016 by reference and replaces the QSR from 2 February 2026. Covers the structure of the QMSR, key differences vs. ISO 13485, and how to transition a QSR system.
ISO 14971:2019 - Risk Management Medical Devices
Application of risk management to medical devices
The harmonised risk management standard. Covers terminology, the risk management process, risk analysis and evaluation, risk control, residual-risk and benefit-risk analysis, and production/post-production information.
EU MDR — Regulation (EU) 2017/745
Placing medical devices on the EU market
The European Union's Medical Devices Regulation. Covers economic-operator obligations, classification, GSPRs, clinical evaluation and PMCF, post-market surveillance, vigilance, UDI and EUDAMED.
ISO 13485:2016 - Quality Management System for Medical Devices
Quality Management Systems for Medical Devices
The international QMS standard for medical device organisations. Covers scope, documentation, management responsibility, resources, product realisation, and measurement & improvement — clause by clause.
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