JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
REGULATORY ASPECTS OF MEDICAL DEVICES LAB
M.Pharmacy I Year II Semester (R22)
List of Experiments:
1. Checklists for 510k and PMA for US market
2. Checklist for CE marking for various classes of devices for EU
3. STED Application for Class III Devices
4. Audit Checklist for Medical Device Facility
5. Clinical Investigation Plan for Medical Devices
6. Preparation and submission of medical devices for approval (3 products)
7. GMP of manufacturing of medical devices of diverse nature (3 products)
8. preparation and submission of nutraceuticals devices for approval (3 products) Practical work shall be carried out based on the theory syllabus M.Pharm I Year III Sem (Pharmaceutical Regulatory Affairs)