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19 of 19 courses
ISO 13485 Quick Refresher — Recap the Essentials Before Your Next Audit
A fast, practical recap of ISO 13485:2016 for busy quality professionals.
A free, bite-sized refresher on ISO 13485:2016 for people who already know the standard. Six micro-lessons recap the QMS essentials — documents, management review, competence, design and supplier control, CAPA and audit readiness — with bullet-point summaries, practical tables, common audit mistakes and a 10-point self-check. Finish with a 15-question scenario quiz and earn a free certificate.
Good Laboratory Practice (GLP) for the Medical Device Industry
Run audit-ready medical-device laboratories: OECD GLP, ISO 13485, ISO/IEC 17025, data integrity and OOS investigations.
A free, professional 18-module course for medical-device laboratories. Learn exactly when formal OECD GLP / 21 CFR 58 applies and when ISO 13485 and ISO/IEC 17025 govern your lab, then master equipment calibration, method validation, sample traceability, ALCOA+ data integrity, tensile, seal-strength, packaging-integrity, absorbency and microbiology testing, OOS/OOT, deviations, CAPA, computerised systems, QC and internal audits. Includes five full case studies, downloadable SOPs, logs, registers and forms, quizzes every three lessons, a 30-question final assessment with explanations (80% to pass) and a free certificate. Prerequisite: basic laboratory or quality experience is helpful but not required.
ISO 9001:2026 — Requirements & Transition from ISO 9001:2015
Understand the updated ISO 9001 and move your QMS from the 2015 version with confidence.
A free, practical course on the revised ISO 9001 quality management standard. Compare ISO 9001:2015 with the 2026 revision clause by clause, learn what is new (climate change, quality culture, ethics, risks and changes), and follow one company through gap analysis, transition planning and the certification audit — with tables, flowcharts, worked examples, knowledge checks, a final assessment and a free certificate.
ISO 13485: From Requirements to Real-World Implementation
Hands-on ISO 13485:2016 — build, run and audit a real medical-device QMS.
A free, practical course that shows how to implement ISO 13485:2016 in a real medical-device company. Follow one company from gap analysis to certification with filled-in example documents, step-by-step guides, shop-floor scenarios, audit mistakes to avoid and workplace tasks — plus scenario-based knowledge checks, a final assessment and a free certificate.
MDSAP Fundamentals & Audit Readiness
Understand the Medical Device Single Audit Program and walk into your next audit prepared.
A beginner-friendly, practical course on the Medical Device Single Audit Program. Learn the participating regulatory authorities, the MDSAP Audit Model and its chapters, how MDSAP builds on ISO 13485:2016, the grading of nonconformities, the questions auditors actually ask and the evidence they expect - with short lessons, tables, flowcharts, case studies, key takeaways and audit tips, checkpoint knowledge checks and a final certification assessment.
Medical Device Design & Development: From Concept to Commercialization
Master the full design-control life-cycle — from an unmet clinical need to a globally launched, post-market monitored medical device.
A structured, easy-to-learn course that walks through every stage of medical device design and development: regulatory landscape, design controls, risk management, usability, software, biocompatibility, electrical safety, verification, validation, design transfer, regulatory submissions, post-market surveillance, and commercialisation. Rich with tables, workflow diagrams, quick-reference notes, and a certification examination.
CAPA Fundamentals: A Practical Guide for Medical Devices
Investigate quality problems, act on root causes, and demonstrate lasting effectiveness.
A practical, easy-to-understand guide to corrective and preventive action in the medical device industry. Learn with realistic examples, decision tables, workflows, quick-reference notes, and an end-of-course certification examination.
Sterilization Basics for Medical Devices: Principles, Methods & Regulatory Requirements
Master essential sterilization principles, methods, and regulatory compliance for medical devices.
This course provides a foundational understanding of medical device sterilization, covering the core principles, various sterilization modalities, and critical regulatory requirements. Participants will learn about the importance of sterilization, the science behind different methods, and the quality system considerations necessary for ensuring device safety and efficacy.
Lean Manufacturing & Six Sigma Fundamentals for Medical Devices
Drive quality, efficiency, and compliance in medical device manufacturing with proven methodologies.
Master Lean and Six Sigma principles to optimize processes, eliminate waste, and enhance product quality. This course provides a comprehensive framework, from 5S and VSM to DMAIC and root cause analysis, tailored for the regulated medical device industry.
Fundamentals of Good Documentation Practices (GDP) for Medical Devices
Master essential documentation rules to ensure compliance and data integrity.
Learn the core principles of GDP, including how to create, modify, and maintain accurate records. This course covers regulatory requirements like 21 CFR Part 820 and ISO 13485, ensuring your documentation supports product safety and quality.
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.
Process Validation Fundamentals for Medical Devices: A Beginner's Guide
Master the essentials of process validation to ensure product quality and regulatory compliance.
This course provides a foundational understanding of process validation for medical devices. Learn the key principles, regulatory requirements, and documentation practices, from Installation Qualification (IQ) to Performance Qualification (PQ). Build the skills to support robust and compliant manufacturing processes.
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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