B.E. (Biomedical Engineering) Medical Devices Regulations Abbreviated As MDR Syllabus - Mumbai University 2026
This is the Fourth Year Biomedical Rev 2019 C Scheme syllabus under REV-2019 'C' Scheme, in force from the academic year 2022-23. The University has not yet published an NEP 2020 syllabus above Semester IV for this branch, and this is the scheme its examinations are set on.
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Syllabus for Medical Devices Regulations (Abbreviated as MDR)
Module 1
- Overview of regulatory framework for medical devices: Credibility and authority of approvals, medical devices life cycle, risk-based classification, risk-based approach for regulatory controls. Introduction to International Regulatory Requirements & Device Pathways.
Module 2
- Safety & Effectiveness: Principles of safety and effectiveness, Quality management system, Standards, Risk management, Cybersecurity, Clinical evaluation. Classification of Biomedical Instruments, based on safety standards, Approach to Bioethics
Module 3
- Technical Documentation: Technical documentation required by regulators, Essential requirements checklist, Risk management summary report, Manufacturing information, Regulated product submissions, Regulatory submission repository
Module 4
- Premarket phase: Design controls, Information management during premarket phase, R&D planning stage, Design & development process stage, product identification & traceability, Case study
Module 5
- Regulatory submissions, approvals and registration : Administrative provisions, regulatory submission and approval, International scenario
Module 6
- Post market phase: Product launch, continued regulatory compliance, Post market surveillance, Product obsolescence, Quality management system, Regulatory system, and processes. Types of medical device audits. Medical device Compliance Audit
Textbooks
- 1 Medical device regulatory practices, Val Theisz, PAN Satnford Publishing
- 2 Handbook of Medical Device regulatory affairs in Asia, edited by Jack Wong and Raymond KY Tong
- 3 Medical Device Regulations: Global Overview and Guiding Principles, Michael Cheng, World Health Organization.
- 1 Daniel A. Vallero - Biomedical Ethics for Engineers_ Ethics and Decision Making in Biomedical and Biosystem Engineering (Biomedical Engineering Series)-Academic Press
- 2 Encyclopedia of Medical Devices and Instrumentation: John G. Webster. Vol. I, II, III, IV (Marcel Dekkar Pub).
- 3 Ethics for Biomedical Engineers, Jong Yong Abdiel Foo, Stephen J. Wilson, Andrew P. Bradley, Winston Gwee, Dennis Kwok-Wing Tam (auth.) , Springer-Verlag New York Theory Examination:
Reproduced from the University of Mumbai syllabus for B.E. (Biomedical Engineering) under REV-2019 'C' Scheme, in force from the academic year 2022-23. Wording is as printed in that syllabus. Module numbering is as printed there too.
The complete syllabus
This subject is cut from the University circular for its year. Open a document here if you want the whole thing rather than a single subject.