Syllabus For Medical Devices
Syllabus For Medical Devices
7. Challenges to regulations
Module 10: Introduction to Risk Management to Medical Devices
1. Documentation requirements
2. Failure Mode Effect Analysis (FMEA)
3. Fault Tree Analysis (FTA)
4. Hazard Analysis and Critical Control Points (HACCP)
Module 11: Biocompatibility Studies
General Idea about Biological evaluation of medical devices ISO 10993
Part 1 to Part 20
Detailed analysis of common specific tests:
1. Cytotoxicity
2. Sensitization
3. Irritation/ intra - cutaneous Toxicity
4. Acute Systemic Toxicity
5. Sub Chronic Toxicity
6. Genotoxicity
7. Implantation
8. Hemocompatibility
9. Chronic toxicity
10. Carcinogenecity
Module 12: Clinical Trials: Medical Devices
1. US FDA: Investigational Device Exemption & GCP
a) Investigational Device Exemption - 21 CFR Part 812
b) Protection of human subjects - 21 CFR Part 50
c) Institutional Review Board - 21 CFR Part 56
d) Financial disclosure by clinical investigators - 21 CFR Part 54
e) Design controls - 21 CFR Part 820 Subpart C
2. Clinical investigation of Medical Devices for human subjects Good Clinical
Practice - ISO 14155
3. Difference
between ISO 14155 and International Conference on
Harmonization Good Clinical Practice
4. Indian Perspective Drugs & Cosmetics Act, Schedule Y
Module 13: Overview of In Vitro Device Regulation
1. US Perspective
a) Classification
b) Information about general purpose reagent and analyte specific
reagents
c) Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)
d) Pre submission process
Pre market notification 510(k)
Pre market Approval
e) Labeling Requirements
f) In vitro Device Listing
g) In vitro Device Reporting
2. EU Perspective