Medical Device Regulations detailed syllabus for Biomedical Engineering (BME) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BME students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Biomedical Engineering 5th Sem scheme and its subjects, do visit BME 5th Sem 2021 regulation scheme. For Professional Elective-II scheme and its subjects refer to BME Professional Elective-II syllabus scheme. The detailed syllabus of medical device regulations is as follows.
Course Objectives:
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Unit I
MEDICAL DEVICE REGULATIONS
History of medical device regulation, regulatory affairs professional’s roles, required competencies, medical device classification: scope, definitions, main classifications, Risk based classification, practical examples, labeling of medical devices: definition, elements, risk management, clinical evaluation and labeling, language level and intended users. differentiating medical devices IVDs and combination products from that of pharmaceuticals.
Unit II
ISO STANDARDS
ISO 13485:2016: Requirements for regulatory purposes: Quality Management Systems, certification process. ISO 14971: Application of Risk management to medical Devices.
Unit III
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Unit IV
INDIAN REGULATORY SYSTEM
India: Medical device regulatory system: market environment, functions undertaken by DGGI, central government, FDA and state governments, guidance documents, details of key regulators, IMDRF and CDSCO, regulatory overview in India, product registration on conformity assessment, quality system regulation, technical material and labeling requirements, commercial aspects, upcoming regulation changes.
Unit V
CLINICAL TRIALS AND DIGITAL REGULATIONS
Regulatory strategy and competitive advantage, Preclinical and Clinical Trial Design for Medical Devices in India; FDA approved devices, post-market surveillance/vigilance, Digital health regulations: Connected care, intelligent design control, reducing design time and cost with in-silico clinical trials
Course Outcomes:
On completion of the course, the student should be able to:
- Define and explain the basic concepts of medical device regulations.
- Decipher the meaning of ISO standards from a regulatory perspective.
- Explain US-FDA, IEC and European regulations.
- Discuss regulations in India
- Explain the regulatory aspects of clinical trials and digital alternatives
Text Books:
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Reference Books:
- Reliable Design of Medical Devices, Second Edition by Richard Fries, CRC Press, 2006
- Medical Device Quality Assurance and Regulatory Compliance by Richard C Fries, CRC Press, 1998.
- Product Safety in the European Union by GaborCzitan, Attila Gutassy, Ralf Wilde, TUVRheinlandAkademia, 2008.
Online Resources
- Regulatory requirements for medical devices including in vitro diagnostics in India (Version 2.0), IIT Madras, Prof. Arun B.Ramteke, Prof. Aseem Sahu, Prof. Malay Mitra.
- https://nptel.ac.in/courses/127106136
- World Health Organization. (2003). Medical device regulations : global overview and guiding principles. World Health Organization.
- https://apps.who.int/iris/handle/10665/42744
- FOOD AND DRUG ADMINISTRATION USA,
- http://www.fda.gov/medicaldevices/deviceregulationandguidance/default.html
For detailed syllabus of all the other subjects of Biomedical Engineering 5th Sem, visit BME 5th Sem subject syllabuses for 2021 regulation.
For all Biomedical Engineering results, visit Anna University BME all semester results direct link.