The Medical Device Regulatory Compliancemanufacturing, testing, approval, and post-market surveillance of medical devices. This course is designed to equip learners with the knowledge of international regulatory frameworks such as FDA (U.S.), CE Marking (Europe), and ISO 13485 standards. Participants will gain expertise in documentation control, clinical evaluation, risk management, and regulatory submission procedures, ensuring that medical devices meet global quality and safety requirements.
By the end of the program, learners will be able to interpret complex compliance requirements, prepare regulatory submissions, and effectively communicate with health authorities and notified bodies. This certification is ideal for professionals aspiring to build a career in regulatory affairs, quality assurance, or product development within the medical device industry.
Module 1: Introduction to Medical Devices and Regulatory Environment Overview of the global medical device industry Classification of medical devices (Class I, II, III) Key regulatory bodies: FDA, EMA, CDSCO, WHO, TGA, etc. Regulatory lifecycle overview — from concept to commercialization Global harmonization and role of IMDRF.
Module 2: Global Regulatory Frameworks & Standards U.S. FDA regulatory requirements (21 CFR Parts 807, 820, 803, 806) European MDR 2017/745 & IVDR overview ISO 13485:2016 – Quality Management System for Medical Devices Role of notified bodies and conformity assessments Overview of regulations in India (CDSCO), Japan (PMDA), and Canada (Health Canada).
Module 3: Quality Management Systems (QMS) for Medical Devices Principles of QMS and documentation control Device Master Record (DMR), Design History File (DHF), and Device History Record (DHR) CAPA (Corrective and Preventive Actions) management Internal audits and management review processes Integration of QMS with product development.
Module 4: Risk Management and ISO 14971 Compliance Risk management principles and terminology Risk analysis, evaluation, control, and monitoring FMEA (Failure Modes and Effects Analysis) Risk-benefit analysis and post-market feedback integration Preparation of Risk Management Files (RMF).
Module 5: Clinical Evaluation, Safety & Performance Requirements Clinical data requirements under EU MDR and FDA regulations Clinical Evaluation Reports (CER) preparation Post-market clinical follow-up (PMCF) Adverse event reporting and vigilance systems Ethical considerations in medical device trials.
Module 6: Regulatory Submissions & Product Registration FDA submission types: 510(k), PMA, De Novo, IDE EU CE Marking process and technical documentation India regulatory submissions through SUGAM portal (CDSCO) Compilation of regulatory dossiers and design dossiers Country-specific registration pathways.
Module 7: Post-Market Surveillance (PMS) and Vigilance PMS system design and implementation Complaint handling and CAPA management Incident reporting and recall procedures PMS Plan and Periodic Safety Update Reports (PSUR) Lifecycle management and continuous improvement.
Module 8: FLabeling requirements under FDA and MDR Instructions for Use (IFU) and language requirements Unique Device Identification (UDI) systems Packaging validation and sterility assurance Environmental and sustainability considerations
Module 9: Audits, Inspections, and Regulatory Communication Preparing for FDA, EU, and ISO audits Common audit findings and corrective actions Regulatory inspection readiness Communication with authorities and notified bodies Documentation practices during inspections.
Module 10: Emerging Trends & Future of Medical Device Compliance Digital health and software as a medical device (SaMD) AI/ML-enabled device compliance challenges Cybersecurity and data protection (GDPR, HIPAA) Green compliance and sustainability in device design Career path and professional certifications (RAPS, RAC).
Mobile: 9100348679
Email: coursedivine@gmail.com
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