Post Graduate Diploma in Medical Device Management

"Gain expertise in managing medical device products with our PG Diploma in Medical Device Management. Learn regulatory compliance, quality assurance, and product development strategies. Enroll now and advance your career in the thriving medical device industry."

Advanced 0(0 Ratings) 1 Students enrolled English
Created by Vaishali Deshpande
Last updated Thu, 30-Mar-2023
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Course overview

Looking to advance your career in the thriving medical device industry?

Our PG Diploma in Medical Device Management can help you gain expertise in managing medical device products.

In this comprehensive program, you'll learn about regulatory compliance, quality assurance, and product development strategies. Our expert faculty will guide you through the entire process of medical device management and help you develop the necessary skills to succeed in this exciting field.

Whether you're new to the industry or looking to enhance your existing knowledge, this program is designed to help you succeed. With a focus on practical, real-world applications, you'll gain the knowledge and skills you need to excel in your career.

Our program is designed to be flexible and accessible, with online learning modules that can be completed on your own schedule. Plus, our faculty is always available to answer your questions and provide guidance along the way.

This course will cover everything you need to know to start your career, including:

  • Introduction to Medical Devices, In –vitro devices, Biologics & Combination Products:  
  • Good Manufacturing Practices (National & International Perspective) 
  • Quality Management System (International Perspective) 
  • Medical Device Regulatory Affairs (International perspective, USA,EU)  
  • Medical Device Regulatory Affairs (Indian perspective) 
  • Introduction to Risk Management to Medical Devices 
  • Biocompatibility Studies 
  • Clinical Trials: Medical Devices 
  • Overview of In – Vitro, Combination Products Device Regulation 
  • Artificial Intelligence in Medical Devices 

Enroll now and take the first step towards advancing your career in the medical device industry. With our PG Diploma in Medical Device Management, you'll gain the skills and expertise you need to succeed.

Go ahead and click the enroll button, and I'll see you in lesson 1!

What will i learn?

  • Knowledge of medical device industry
  • You will be job ready for medical device domain
  • Stake holders of Medical Device
  • What is the career pathway in Medical Devices
  • Biocompatibility Studies
  • Clinical Trials: Medical Devices
  • Good Manufacturing Practices
  • Medical Device Regulatory Affairs
  • Introduction to Risk Management to Medical Devices
Requirements
  • Ideally who has completed their graduation in science, pharmacy, BTech, Biotech, Biomedical, Instrumental or ailed branch also who are interested in medicine field
Curriculum for this course
73 Lessons 13:11:40 Hours
Introduction to Medical Devices
5 Lessons 00:40:30 Hours
  • Introduction to Medical Devices
    00:14:43
  • Combination Products Medical Device
    00:07:14
  • Terminologies in Medical Devices
    00:11:29
  • In-Vitro Medical Device
    00:07:04
  • Introduction to Medical Device - Notes
    .
Good Manufacturing Practices
5 Lessons 01:08:01 Hours
  • Good Manufacturing Practices I-A
    00:14:28
  • Good Manufacturing Practices I-B
    00:12:43
  • Good Manufacturing Practices II-A
    00:18:43
  • Good Manufacturing Practices II-B
    00:22:07
  • Good Manufacturing Practices - Notes
    .
Introduction to GCP
10 Lessons 02:48:41 Hours
  • Responsibilities of Ethics Committee Members
    00:31:35
  • History Development of International Regulations in Clinical Research
    00:18:14
  • Good Clinical Practices
    00:12:04
  • Ethics committee
    00:13:46
  • Investigator Responsibilities
    00:13:40
  • Sponsor Responsibilities
    00:38:22
  • Protocol and Investigator Brochure
    00:06:56
  • Essential Documents
    00:34:04
  • Good Clinical Practices- Notes
    .
  • Good Clinical Practices- Quiz
    00:00:00
Introduction to Regulatory Affairs
4 Lessons 00:51:38 Hours
  • Introduction to Regulatory Affairs
    00:09:41
  • Introduction to Regulatory Affairs - Medical Device
    00:08:09
  • International Regulations and Initiatives
    00:17:18
  • CDSCO
    00:16:30
Medical Device Regulatory Affairs (International perspective, USA,EU)
11 Lessons 02:10:22 Hours
  • Medical Devices US and EU
    00:15:27
  • Medical Device and Regulation EU
    00:05:38
  • Medical Device Regulation EU II - A
    00:17:54
  • Medical Device Regulation EU II - B
    00:26:18
  • Medical Device Regulation EU II - C
    00:18:45
  • FDA Regulation I
    00:19:39
  • FDA Regulation II
    00:26:41
  • Medical Device Regulatory Affairs (International perspective) - Notes -1
    .
  • Medical Device Regulatory Affairs (International perspective) - Notes -2
    .
  • Medical Device Regulatory Affairs (International perspective) - Notes -3
    .
  • Medical Device Regulatory Affairs (International perspective) - References
    .
Medical Device Regulatory Affairs (Indian perspective)
10 Lessons 01:38:12 Hours
  • Medical Device Registration in India
    00:15:55
  • Medical Device in India I
    00:17:41
  • Medical Device in India II
    00:26:11
  • Regulatory Affairs India I
    00:22:30
  • Regulatory Affairs India II
    00:15:55
  • MDR (India Perspective) - Notes-1
    .
  • MDR (India Perspective) - Notes-2
    .
  • MDR (India Perspective) - Notes-3
    .
  • MDR (India Perspective) - Notes-4
    .
  • MDR (India Perspective) - FAQ
    .
Quality Management System
7 Lessons 01:22:37 Hours
  • Introduction to Quality Management Susyem in Medical Devices
    00:07:10
  • Overview of Quality Systems Regulation
    00:21:50
  • Quality Management FDA - I
    00:17:41
  • Quality Management FDA - II
    00:17:46
  • ISO 13485 - Medical Devices - QMS
    00:18:10
  • Quality Management Notes
    .
  • Quality Management Reference
    .
Introduction to Risk Management to Medical Devices
7 Lessons 01:14:44 Hours
  • Introduction to Risk Management
    00:11:58
  • Medical Device Risk Management
    00:21:23
  • Quality Risk Managment of Medical Devices
    00:17:26
  • Risk Based CAPA
    00:23:57
  • Risk Management to Medical Devices Notes-1
    .
  • Risk Management to Medical Devices Notes-2
    .
  • Risk Management to Medical Devices Reference
    .
Biocompatibility Studies
2 Lessons 00:15:31 Hours
  • Biocompatability in Medical Devices
    00:15:31
  • Biocompatibility Studies Notes
    .
AI in Clinical Trials & Medical Devices
3 Lessons 00:33:30 Hours
  • AI in Healthcare- An Introduction
    00:10:44
  • Clinical Trials in Medical Device
    00:15:07
  • Machine Learning and Artifical Intelligence in Medical Device
    00:07:39
Safety Reporting in Medical Devices
3 Lessons 00:27:54 Hours
  • Safety Reporting
    00:06:45
  • Medical Device Reporting I
    00:05:51
  • Medical Device Reporting II
    00:15:18
General Books
6 Lessons 00:00:00 Hours
  • QUALITY ASSURANCE AND REGULATORY AFFAIRS FOR THE BIOSCIENCES
    .
  • Foundations and Strategies for Medical Device Design
    .
  • Decommissioning Medical Devices
    .
  • A COMPLETE GUIDE TO BRINGING A MEDICAL DEVICE TO MARKET
    .
  • DEVICE MASTER RECORDS
    .
  • Biomedical Engineering
    .
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Vaishali Deshpande

90 Reviews | 780 Students | 15 Courses
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