Course

Unit 1

Medical Devices and Nanomedicine: Introduction; Risk based classification; Product Lifecycle: Design and Development, Biological evaluation (both in vitro and in vivo studies) as per ISO 10993, Phase 1 to Phase 3 clinical Trials; Marketing; Regulators bodies like CDSCO, FDA and EU; Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)

Unit 2

Quality System Regulations of Medical Devices: ISO 13485; Schedule Y for drugs; Standard Operating Procedures; Validation and Verification Process; Quality Control System; Documentation and Records; Quality Risk Management: ISO 14971

Unit 3

Clinical Investigation of Medical Devices and nanomedicine; New Drug or Device Application and its approval; Good Clinical Practice for Clinical Investigation of medical devices (ISO 14155:2011); Medical Device Rule 2017; Adverse Event Reporting.

Pre-requisites: Basic level biology and chemistry

Total number of classes: 45

COURSE OUTCOMES:

Upon successful completion, students will have the knowledge to the:

• Product Lifecycleand quality considerations of medical devices or nanomedicine
• Regulatory requirement for approval of medical devices or nanomedicine
• Good Manufacturing Practice Requirement and Quality Assurance
• Clinical investigation of medical devices or nanomedicine

• Medical Device Development: A Regulatory Overview by Jonathan S. Kahan, Parexel Intl Corp; 3rd edition, 2014
• Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices by John J. Tobin and Gary Walsh, Wiley-Blackwell (1st edition), 2008
• Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics by Carmen Medina, CRC Press, 2019